System One is currently seeking a Subcontract Admin III to support a construction project located in Port Arthur, TX! Primary Position Objective: The Subcontract Administrator III is responsible for the documentation, coordination, and direction of subcontract administration activities once the subcontract is executed. The Subcontract Administrator III is typically assigned to assist the Subcontract Manager with the management of project-based subcontractors with a focus on issue coordination, progress verification and reporting, invoicing validation, safety, and quality. Position Responsibilities: Support Request for Proposal (RFP) process Support pre-bid site visits and/or pre-bid conferences and site requirements. Support subcontract mobilization for construction. Support pre-mobilization meetings with each subcontractor/service provider. Enforce reporting procedures, i.e., schedule of value, progress reports, daily reports. Support coordination of subcontractor work with construction schedules and priorities. Use document control procedures for subcontract documents. Review subcontractor invoices Support subcontractor meetings. Verify progress to project schedule Support change order process Support facilitation of the review and resolution of claims with input from project team Coordinate with procurement to manage subcontractor change order process. Interpret plans and specifications with engineering assistance. Support coordination with local city Inspectors. Support coordination with safety manager to enforce safety programs and site training. Support coordination with project quality control manager to administer quality control program. Support coordination of delivery and installation of owner or client furnished equipment. Support coordination of preliminary inspection. Support coordination of substantial completion inspection. Support coordination of final inspection. Prepare initial punch list. Support systems check-out and start-up. Support close-out procedures and perform final accounting. Support delivery of subcontractor tools and equipment & demobilization. Reports to the jobsite Subcontract Manager while assigned to a project. Other duties as assigned. Required Qualifications: High School, Technical, or Associates degree Minimum of 3-5 years of relevant construction subcontract management experience. Microsoft Office Software: Excel, Word, and PowerPoint • Communication skills (oral and written) Valued but not required skills, knowledge, and abilities: CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Preferred Additional Qualifications: CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Physical Requirements: Employee will be required to communicate in person, via telephone, email, video chat and software systems. Must be able to maneuver around a construction site with rough terrain. Climbing might be required. Must be able to lift 10 lbs. Position may include visits to construction sites and industrial facilities requiring mobility (on ground and at heights) and the use of personal protective equipment (PPE) including but not limited to: hardhat, safety glasses/goggles, ear plugs/muffs, masks/respirators, safety vests, gloves and work boots. Work Environment: Employee will work in multiple environments including an office, warehouse and in a trailer or building on construction sites. On construction sites, noise levels will be moderate to high. Job sites may contain the following: light to heavy equipment vehicles, small to large equipment, materials, communication equipment and tools, people standing, walking, sitting, signaling, and talking. Noise levels vary and may include bells, whistles, and alarms.
09/22/2021
Full time
System One is currently seeking a Subcontract Admin III to support a construction project located in Port Arthur, TX! Primary Position Objective: The Subcontract Administrator III is responsible for the documentation, coordination, and direction of subcontract administration activities once the subcontract is executed. The Subcontract Administrator III is typically assigned to assist the Subcontract Manager with the management of project-based subcontractors with a focus on issue coordination, progress verification and reporting, invoicing validation, safety, and quality. Position Responsibilities: Support Request for Proposal (RFP) process Support pre-bid site visits and/or pre-bid conferences and site requirements. Support subcontract mobilization for construction. Support pre-mobilization meetings with each subcontractor/service provider. Enforce reporting procedures, i.e., schedule of value, progress reports, daily reports. Support coordination of subcontractor work with construction schedules and priorities. Use document control procedures for subcontract documents. Review subcontractor invoices Support subcontractor meetings. Verify progress to project schedule Support change order process Support facilitation of the review and resolution of claims with input from project team Coordinate with procurement to manage subcontractor change order process. Interpret plans and specifications with engineering assistance. Support coordination with local city Inspectors. Support coordination with safety manager to enforce safety programs and site training. Support coordination with project quality control manager to administer quality control program. Support coordination of delivery and installation of owner or client furnished equipment. Support coordination of preliminary inspection. Support coordination of substantial completion inspection. Support coordination of final inspection. Prepare initial punch list. Support systems check-out and start-up. Support close-out procedures and perform final accounting. Support delivery of subcontractor tools and equipment & demobilization. Reports to the jobsite Subcontract Manager while assigned to a project. Other duties as assigned. Required Qualifications: High School, Technical, or Associates degree Minimum of 3-5 years of relevant construction subcontract management experience. Microsoft Office Software: Excel, Word, and PowerPoint • Communication skills (oral and written) Valued but not required skills, knowledge, and abilities: CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Preferred Additional Qualifications: CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Physical Requirements: Employee will be required to communicate in person, via telephone, email, video chat and software systems. Must be able to maneuver around a construction site with rough terrain. Climbing might be required. Must be able to lift 10 lbs. Position may include visits to construction sites and industrial facilities requiring mobility (on ground and at heights) and the use of personal protective equipment (PPE) including but not limited to: hardhat, safety glasses/goggles, ear plugs/muffs, masks/respirators, safety vests, gloves and work boots. Work Environment: Employee will work in multiple environments including an office, warehouse and in a trailer or building on construction sites. On construction sites, noise levels will be moderate to high. Job sites may contain the following: light to heavy equipment vehicles, small to large equipment, materials, communication equipment and tools, people standing, walking, sitting, signaling, and talking. Noise levels vary and may include bells, whistles, and alarms.
Office Assistant Temp to Perm Opportunity! Pay range: $16 - $19/hour Location: Elizabeth, NJ Responsibilities and Qualifications: Must be bilingual in Spanish Basic computer skills Ability to maneuver but no specific skills required, will have guidance and training Provide customer service Answer calls, assist customers with pricing, upselling, and answers to inquiries/pricing information Good personality and communication skills
09/19/2021
Full time
Office Assistant Temp to Perm Opportunity! Pay range: $16 - $19/hour Location: Elizabeth, NJ Responsibilities and Qualifications: Must be bilingual in Spanish Basic computer skills Ability to maneuver but no specific skills required, will have guidance and training Provide customer service Answer calls, assist customers with pricing, upselling, and answers to inquiries/pricing information Good personality and communication skills
System One is working with a major client in the Orlando, FL geographical location who are looking to hire a Senior Piping Designer, SP3D - Gas Turbines, on a 'Contract-to-Hire' basis starting ASAP! Purpose of Position: This position is responsible for developing piping system designs including piping Catalog in SP3D that satisfies code, contract, and schedule requirements for Gas Turbine power projects. Major Responsibilities and Activities : Understanding of piping design philosophy and ability to perform piping designs for high energy and process piping per applicable ASME, ASTM, ANSI codes and publications with knowledge of ASME Section 1, B31.1 & B31.3 as well as ANSI B16 standards. Should be fully conversant with Design procedures as pertains to material section with consideration of the allowable stress values as given in the ASME code. Must be able to analyze pipe routing for allowable stresses and support location. Should be familiar with the use of fixed, variable, and constant load supports and establish where each type shall be employed. In addition, background should include experience of using the "PG" portion of the ASME code with special emphasis on sketching Details for weld joints as used in the fabrication of Steam Generator Pressure Parts. Design and Maintain project / client specific piping specifications and piping parts/components that make up the piping Catalog in SP3D. Manage the loading of all piping specifications and components into SP3D. Manage the transfer of SP3D data between MPW and 3rd party companies. Troubleshoot, diagnose, and repair problem / errors found in the piping catalog and SP3D Piping Tool for projects. Experience in 3D software like SP3D, Capable of 3D modelling and 2D drawing extraction development of Piping detail drawings. Understanding and developing plot/plant layout concept, reviewing, checking, and advising direction associated with plant layout Prepare piping arrangements, isometric, construction, and spool drawings for field and shop fabrication. Clash check comment incorporation Interface with other department. Review of vendor drawings, 3D Model, and Isometrics. Other Duties Review's drawings, and vendor equipment documentation, both within the discipline as well as from other disciplines for compliance with project requirements and actively seeks resolution. Develop processes and procedures that will ensure an effective and optimized use of resources while providing high quality design packages. Interface and gather information from other disciplines to be used for developing the design. Proficient in 2D AutoCAD, MicroStation, SP3D, SmartPlant review capabilities, as required. Should be able to work independently. Generating standard design instructions associated with piping engineering. Conduct necessary fieldwork inclusive of walk downs of current systems, locate tie-ins and measuring. Review project parameters related to piping requirements. Protect Company confidential information by not communicating, disclosing, or using for benefit of third parties and always maintain the highest degree of honesty and integrity. Ability to perform multi-tasks and perform multidisciplinary communication. Education / Experience Requirements: Diploma. Minimum fifteen (15) years of directly related technical experience. Desirable But Not Required: Associate Degree. Ability to export 3D models into pipe stress software (e.g., Caesar II). #LI-FF1
09/12/2021
Full time
System One is working with a major client in the Orlando, FL geographical location who are looking to hire a Senior Piping Designer, SP3D - Gas Turbines, on a 'Contract-to-Hire' basis starting ASAP! Purpose of Position: This position is responsible for developing piping system designs including piping Catalog in SP3D that satisfies code, contract, and schedule requirements for Gas Turbine power projects. Major Responsibilities and Activities : Understanding of piping design philosophy and ability to perform piping designs for high energy and process piping per applicable ASME, ASTM, ANSI codes and publications with knowledge of ASME Section 1, B31.1 & B31.3 as well as ANSI B16 standards. Should be fully conversant with Design procedures as pertains to material section with consideration of the allowable stress values as given in the ASME code. Must be able to analyze pipe routing for allowable stresses and support location. Should be familiar with the use of fixed, variable, and constant load supports and establish where each type shall be employed. In addition, background should include experience of using the "PG" portion of the ASME code with special emphasis on sketching Details for weld joints as used in the fabrication of Steam Generator Pressure Parts. Design and Maintain project / client specific piping specifications and piping parts/components that make up the piping Catalog in SP3D. Manage the loading of all piping specifications and components into SP3D. Manage the transfer of SP3D data between MPW and 3rd party companies. Troubleshoot, diagnose, and repair problem / errors found in the piping catalog and SP3D Piping Tool for projects. Experience in 3D software like SP3D, Capable of 3D modelling and 2D drawing extraction development of Piping detail drawings. Understanding and developing plot/plant layout concept, reviewing, checking, and advising direction associated with plant layout Prepare piping arrangements, isometric, construction, and spool drawings for field and shop fabrication. Clash check comment incorporation Interface with other department. Review of vendor drawings, 3D Model, and Isometrics. Other Duties Review's drawings, and vendor equipment documentation, both within the discipline as well as from other disciplines for compliance with project requirements and actively seeks resolution. Develop processes and procedures that will ensure an effective and optimized use of resources while providing high quality design packages. Interface and gather information from other disciplines to be used for developing the design. Proficient in 2D AutoCAD, MicroStation, SP3D, SmartPlant review capabilities, as required. Should be able to work independently. Generating standard design instructions associated with piping engineering. Conduct necessary fieldwork inclusive of walk downs of current systems, locate tie-ins and measuring. Review project parameters related to piping requirements. Protect Company confidential information by not communicating, disclosing, or using for benefit of third parties and always maintain the highest degree of honesty and integrity. Ability to perform multi-tasks and perform multidisciplinary communication. Education / Experience Requirements: Diploma. Minimum fifteen (15) years of directly related technical experience. Desirable But Not Required: Associate Degree. Ability to export 3D models into pipe stress software (e.g., Caesar II). #LI-FF1
System One is currently seeking a Subcontract Admin II to support a construction project located in Port Arthur, TX! Primary Position Objective: The Subcontract Administrator II is responsible for the documentation, coordination, and direction of subcontract administration activities once the subcontract is executed. The Subcontract Administrator II is typically assigned to assist the Subcontract Manager with the management of project-based subcontractors with a focus on issue coordination, progress verification and reporting, invoicing validation, safety, and quality. Position Responsibilities: Support Request for Proposal (RFP) process Support pre-bid site visits and/or pre-bid conferences and site requirements. Support subcontract mobilization for construction. Support pre-mobilization meetings with each subcontractor/service provider. Enforce reporting procedures, i.e., schedule of value, progress reports, daily reports. Support coordination of subcontractor work with construction schedules and priorities. Use document control procedures for subcontract documents. Review subcontractor invoices Support subcontractor meetings. Verify progress to project schedule Support change order process Support facilitation of the review and resolution of claims with input from project team Coordinate with procurement to manage subcontractor change order process. Interpret plans and specifications with engineering assistance. Support coordination with local city Inspectors. Support coordination with safety manager to enforce safety programs and site training. Support coordination with project quality control manager to administer quality control program. Support coordination of delivery and installation of owner or client furnished equipment. Support coordination of preliminary inspection. Support coordination of substantial completion inspection. Support coordination of final inspection. Prepare initial punch list. Support systems check-out and start-up. Support close-out procedures and perform final accounting. Support delivery of subcontractor tools and equipment & demobilization. The Subcontract Administrator II reports to the jobsite Subcontract Manager while assigned to a project. Other duties as assigned. Required Qualifications: High School, Technical, or Associates degree Minimum of 3-5 years of relevant construction subcontract management experience. Microsoft Office Software: Excel, Word, and PowerPoint • Communication skills (oral and written) Valued but not required skills, knowledge, and abilities: CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Preferred Additional Qualifications CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Physical Requirements: Employee will be required to communicate in person, via telephone, email, video chat and software systems. Must be able to maneuver around a construction site with rough terrain. Climbing might be required. Must be able to lift 10 lbs. Position may include visits to construction sites and industrial facilities requiring mobility (on ground and at heights) and the use of personal protective equipment (PPE) including but not limited to hardhat, safety glasses/goggles, ear plugs/muffs, masks/respirators, safety vests, gloves and work boots. Work Environment: Employee will work in multiple environments including an office, warehouse and in a trailer or building on construction sites. On construction sites, noise levels will be moderate to high. Job sites may contain the following: light to heavy equipment vehicles, small to large equipment, materials, communication equipment and tools, people standing, walking, sitting, signaling, and talking. Noise levels vary and may include bells, whistles, and alarms.
09/12/2021
Full time
System One is currently seeking a Subcontract Admin II to support a construction project located in Port Arthur, TX! Primary Position Objective: The Subcontract Administrator II is responsible for the documentation, coordination, and direction of subcontract administration activities once the subcontract is executed. The Subcontract Administrator II is typically assigned to assist the Subcontract Manager with the management of project-based subcontractors with a focus on issue coordination, progress verification and reporting, invoicing validation, safety, and quality. Position Responsibilities: Support Request for Proposal (RFP) process Support pre-bid site visits and/or pre-bid conferences and site requirements. Support subcontract mobilization for construction. Support pre-mobilization meetings with each subcontractor/service provider. Enforce reporting procedures, i.e., schedule of value, progress reports, daily reports. Support coordination of subcontractor work with construction schedules and priorities. Use document control procedures for subcontract documents. Review subcontractor invoices Support subcontractor meetings. Verify progress to project schedule Support change order process Support facilitation of the review and resolution of claims with input from project team Coordinate with procurement to manage subcontractor change order process. Interpret plans and specifications with engineering assistance. Support coordination with local city Inspectors. Support coordination with safety manager to enforce safety programs and site training. Support coordination with project quality control manager to administer quality control program. Support coordination of delivery and installation of owner or client furnished equipment. Support coordination of preliminary inspection. Support coordination of substantial completion inspection. Support coordination of final inspection. Prepare initial punch list. Support systems check-out and start-up. Support close-out procedures and perform final accounting. Support delivery of subcontractor tools and equipment & demobilization. The Subcontract Administrator II reports to the jobsite Subcontract Manager while assigned to a project. Other duties as assigned. Required Qualifications: High School, Technical, or Associates degree Minimum of 3-5 years of relevant construction subcontract management experience. Microsoft Office Software: Excel, Word, and PowerPoint • Communication skills (oral and written) Valued but not required skills, knowledge, and abilities: CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Preferred Additional Qualifications CMIS, Contract Manager, Oracle Procurement module, Hard Dollar Demonstrated understanding of earned value Project Cost Software Physical Requirements: Employee will be required to communicate in person, via telephone, email, video chat and software systems. Must be able to maneuver around a construction site with rough terrain. Climbing might be required. Must be able to lift 10 lbs. Position may include visits to construction sites and industrial facilities requiring mobility (on ground and at heights) and the use of personal protective equipment (PPE) including but not limited to hardhat, safety glasses/goggles, ear plugs/muffs, masks/respirators, safety vests, gloves and work boots. Work Environment: Employee will work in multiple environments including an office, warehouse and in a trailer or building on construction sites. On construction sites, noise levels will be moderate to high. Job sites may contain the following: light to heavy equipment vehicles, small to large equipment, materials, communication equipment and tools, people standing, walking, sitting, signaling, and talking. Noise levels vary and may include bells, whistles, and alarms.
Administrative Assistant II Denver, CO 80239 System One is actively seeking an Administrative Assistant for a contract position located in Denver, CO. Administrative Assistant Responsibilities: Perform a wide variety of administrative duties, under limited supervision, utilizing knowledge of established practices and procedures, and following general guidelines of supervisor Conduct special assignments to assist managers in administering their operations Suggest measures to improve customer relations Produce a variety of documents using various software packages Manipulate data on existing spreadsheets and/or database software programs, applying new formulae and formats, as applicable Answer and route telephone calls, transmit decisions and instructions for supervisor and maintain supervisors calendar Investigate and answer inquiries of a non-routine nature and respond to complaints, as authorized Coordinate a variety of activities and conduct complex investigations, in direct support of senior managers Recommend measures to achieve operating efficiencies and ensure customer satisfaction Monitor activities, provide support, and, as authorized, approve changes in specifications, priorities and schedules Resolve or provide expertise in resolving complex problems Maintain communications among managers and other staff, and provide information regarding such matters as internal operating policies, regulations, business developments, and focus and objectives of the organization Administrative Assistant Requirements: High School Diploma SAP experience Industrial background (preferred) / Industrial Motor and generator experience is a plus Customer service experience Proficient in Excel and Microsoft Office Organized Attention to detail Purchasing experience Self-Starter, driven to accomplish laid out goals and operate within set guidelines with minimal supervision Ability to multi task, but setting priorities for tasks assigned Some Managerial experience (Can lead a team/ meeting) Can think outside of the box and problem solve Flexible schedule Duration : Contract Location : Denver, CO
01/31/2021
Full time
Administrative Assistant II Denver, CO 80239 System One is actively seeking an Administrative Assistant for a contract position located in Denver, CO. Administrative Assistant Responsibilities: Perform a wide variety of administrative duties, under limited supervision, utilizing knowledge of established practices and procedures, and following general guidelines of supervisor Conduct special assignments to assist managers in administering their operations Suggest measures to improve customer relations Produce a variety of documents using various software packages Manipulate data on existing spreadsheets and/or database software programs, applying new formulae and formats, as applicable Answer and route telephone calls, transmit decisions and instructions for supervisor and maintain supervisors calendar Investigate and answer inquiries of a non-routine nature and respond to complaints, as authorized Coordinate a variety of activities and conduct complex investigations, in direct support of senior managers Recommend measures to achieve operating efficiencies and ensure customer satisfaction Monitor activities, provide support, and, as authorized, approve changes in specifications, priorities and schedules Resolve or provide expertise in resolving complex problems Maintain communications among managers and other staff, and provide information regarding such matters as internal operating policies, regulations, business developments, and focus and objectives of the organization Administrative Assistant Requirements: High School Diploma SAP experience Industrial background (preferred) / Industrial Motor and generator experience is a plus Customer service experience Proficient in Excel and Microsoft Office Organized Attention to detail Purchasing experience Self-Starter, driven to accomplish laid out goals and operate within set guidelines with minimal supervision Ability to multi task, but setting priorities for tasks assigned Some Managerial experience (Can lead a team/ meeting) Can think outside of the box and problem solve Flexible schedule Duration : Contract Location : Denver, CO
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
01/30/2021
Full time
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
01/30/2021
Full time
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
01/30/2021
Full time
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
01/29/2021
Full time
This is a permanent, full time, direct hire job opportunity in Hornell, NY (~70 miles south from Rochester, NY) offering W2 annual salary with full benefits and relocation assistance Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly. Finance Project Manager (Project Controller): - Will ensure the conditions that are necessary for achievement of the Project's financial targets are met - Provide economic and financial advice to the Project Manager - Together with the Project Manager will preprare periodic Project Reviews, including the project cost monitoring and financial analysis - Make sure that customer invoicing is done as soon as possible and play an active role in achieving payment from customer when due. Process supplier invoices for payment are completed timely. - Specifically follow up the implementation of cash improvement actions and promote the cash culture in the project team - Monitor project costs, searching for cost reduction and improvement of inventories along with scheduling, engineering and manufacturing issues - Will be responsible for the financial monitoring and reporting for larger projects in excess of three hundred million dollars in contract value or several smaller projects were close control and reporting is necessary to achieve planned results Skills, Experience, Education: - Bachelor's or Master's degree in such disciplines as: Finance, Accounting, Economics, Business Administration - Previous full time finance / accounting experience experience working as a Finance Project Manager, Finance Manager, Controller (project controller), Cost Accountant (experience with cost accounting will be a plus) - ideally for manufacturing, industrial, engineering companies - Nice to have SAP ERP experience Please send me your details (resume, work authorization status, current location, availability and compensation expectations) directly to: for an immediate consideration. Make sure to include both the job title and location of the job if you email me directly.
Job Title: Lab Technician Location Allentown Responsibilities: Responsible for day to day operations including research and development, manufacturing, inspection, and testing. • Responsible for preparation of materials for in-process and final release testing, including, but not limited to, physical property. This can include sampling, testing, measuring, recording and analyzing results. Provides technical support when needed, while adhering to all applicable procedures. Uses a variety of test equipment/instruments, assists in maintaining acceptable performance of equipment/instruments (e.g. calibration/verification) and assists in keeping applicable procedures updated. Responsible for all activities regarding incoming raw material inspection, in-process inspection, finished product inspection, and/or non-conformance reporting. Assist in updating existing quality documents or creating new documents and other QA/QC Department functions as required.
01/28/2021
Full time
Job Title: Lab Technician Location Allentown Responsibilities: Responsible for day to day operations including research and development, manufacturing, inspection, and testing. • Responsible for preparation of materials for in-process and final release testing, including, but not limited to, physical property. This can include sampling, testing, measuring, recording and analyzing results. Provides technical support when needed, while adhering to all applicable procedures. Uses a variety of test equipment/instruments, assists in maintaining acceptable performance of equipment/instruments (e.g. calibration/verification) and assists in keeping applicable procedures updated. Responsible for all activities regarding incoming raw material inspection, in-process inspection, finished product inspection, and/or non-conformance reporting. Assist in updating existing quality documents or creating new documents and other QA/QC Department functions as required.
Front Desk Receptionist Hours: will be between 9:30 am-6pm (8 hours) Pay Range: $19.23 - $21.15 (40k - $44k) Duration: Temp to Perm Duties and Responsibilities: Check VM Messages Check Balance on Postage machine and log the start Amount & ink level Correspond to various emails, FD calls, Rollover call, 2901 calls (All day task) Check Calendar & Emails for daily appts for phone lists and enter accordingly Daily phone hours and extension - update daily as they are emailed from each entity/ email completed list to A/R, Customer care, Residential Receptionist USPS Mail gets sorted/ slit and stamped the day they come in a distributed to each Mailbox accordingly (Please see mail cheat sheet) Create priority & UPS labels for outgoing mail process Check mail & UPS bins for any outgoing mail and process Enter/update/code daily Phone internet bills and distribute Check pickups - Log/date/ Name/ when check is handed to receiver Enter daily Tally's for rollover calls FedEx, UPS & any deliveries get logged and distributed Assist Housekeeper with Petty cash & log in spreadsheet for monthly report If there is any leftover outgoing mail, take to the mailbox across the street Check sign in/sign out sheet - I normally let Lindsay know how many employees are left in the bldg.. End of day Closing: Put Phones on night, shut down mail one, printer, Clear FD Counter, Lock FD door Weekly: Enter/scan/email weekly rollover tallys Update and Print weekly - Sign-in sheets, Visitors Sheets, Outside visitor Sheets, Daily Tally and rollover sheet. Update FD Logs (Business cards/Phone Log/Check pick up/Entity & payments) Stock Board room with supplies - if low (Exp: Pens tape clips) Open Supply Closet- With Signed Order supply, list we distribute supplies in house. Monthly: Update/Process Petty cash spreadsheet and receipts accordingly with Greg each month. Update/ Print and email extension lists or when needed Check stock on all supplies - office supplies, UPS supplies, Priority supplies, toners etc. And process orders Quarterly: Work with Superior on meter reads reports for & Entities remotely Semi Annual: Gather a bin count and place order, check divide order per list, process damaged bins report for replacements or credits Yearly: Gather a Calendar count for the next years calendar order with WB office supplies When in need: Have paper stocked for mailroom printer Enter data to Superiors website when toner supplies are needed for all entities. Enter Data when toner supplies needed for College Pointe Inform Maintenance with any issues and or repairs to be done Process Notices for front doors/bathroom/Elevators (Holiday hrs., pickup/Delivery notices out of order etc.)/ Prepare and distribute supplies for New Hire Assist departments with notices (Stuff, Seal, Mail) Retrieve VM stations and or redirect Update/Revise/Organize FD cheat sheets Keep FD stocked / Organized - any Supplies delivered, open and add to stock
01/28/2021
Full time
Front Desk Receptionist Hours: will be between 9:30 am-6pm (8 hours) Pay Range: $19.23 - $21.15 (40k - $44k) Duration: Temp to Perm Duties and Responsibilities: Check VM Messages Check Balance on Postage machine and log the start Amount & ink level Correspond to various emails, FD calls, Rollover call, 2901 calls (All day task) Check Calendar & Emails for daily appts for phone lists and enter accordingly Daily phone hours and extension - update daily as they are emailed from each entity/ email completed list to A/R, Customer care, Residential Receptionist USPS Mail gets sorted/ slit and stamped the day they come in a distributed to each Mailbox accordingly (Please see mail cheat sheet) Create priority & UPS labels for outgoing mail process Check mail & UPS bins for any outgoing mail and process Enter/update/code daily Phone internet bills and distribute Check pickups - Log/date/ Name/ when check is handed to receiver Enter daily Tally's for rollover calls FedEx, UPS & any deliveries get logged and distributed Assist Housekeeper with Petty cash & log in spreadsheet for monthly report If there is any leftover outgoing mail, take to the mailbox across the street Check sign in/sign out sheet - I normally let Lindsay know how many employees are left in the bldg.. End of day Closing: Put Phones on night, shut down mail one, printer, Clear FD Counter, Lock FD door Weekly: Enter/scan/email weekly rollover tallys Update and Print weekly - Sign-in sheets, Visitors Sheets, Outside visitor Sheets, Daily Tally and rollover sheet. Update FD Logs (Business cards/Phone Log/Check pick up/Entity & payments) Stock Board room with supplies - if low (Exp: Pens tape clips) Open Supply Closet- With Signed Order supply, list we distribute supplies in house. Monthly: Update/Process Petty cash spreadsheet and receipts accordingly with Greg each month. Update/ Print and email extension lists or when needed Check stock on all supplies - office supplies, UPS supplies, Priority supplies, toners etc. And process orders Quarterly: Work with Superior on meter reads reports for & Entities remotely Semi Annual: Gather a bin count and place order, check divide order per list, process damaged bins report for replacements or credits Yearly: Gather a Calendar count for the next years calendar order with WB office supplies When in need: Have paper stocked for mailroom printer Enter data to Superiors website when toner supplies are needed for all entities. Enter Data when toner supplies needed for College Pointe Inform Maintenance with any issues and or repairs to be done Process Notices for front doors/bathroom/Elevators (Holiday hrs., pickup/Delivery notices out of order etc.)/ Prepare and distribute supplies for New Hire Assist departments with notices (Stuff, Seal, Mail) Retrieve VM stations and or redirect Update/Revise/Organize FD cheat sheets Keep FD stocked / Organized - any Supplies delivered, open and add to stock
Job Title: Senior Manager Regulatory Operations Location: Cambridge, MA Type: Full Time, Salaried with Benefits Start Date: Immediate Global Pharmaceutical Company is looking to add a Senior Manger of Regulatory Operations to their team! Responsibilities: Ensures the creation of high-quality regulatory submission packages that meet company requirements along with regulatory agency electronic submission requirements and guidelines, ensuring timely delivery to health agencies Serves as primary interface between internal staff and external vendors, coordinates regulatory meetings and oversees the scheduling and coordinated completion of publishing deliverables. Responsible for development of submission plans, with content timelines and workflow tracking. Ensures organization and maintenance of Health Authority correspondence and regulatory information files. Contributes to the evaluation, testing and implementation of regulatory tools, technology for dossier management, publishing, archiving and submission. Monitors the development of new regulatory requirements or guidances and advises on the impact to the business. Identifies potential risks, developing mitigation plans for resolution of risk factors, along with status and escalation planning. Contributes to development and implementation of regulatory standards and procedures for dossier management, publishing, archiving and submission processes. Advises Clinical Development on products that are in-development, collaborating cross-functionally on preparation and submission of regulatory filings. May be required to perform other duties, as assigned. Requirements : BS degree is required, preferably in the life sciences A minimum of six to eight years of regulatory experience in the pharmaceutical industry, which includes four to six years of managing multiple projects in regulatory operations. Knowledge of drug development and the necessary support operations, and the associated regulatory requirements. Success in regulatory planning, dossier generation, publishing, and submission of all US dossiers; NDA/BLA experience is highly desirable. Demonstrated record of business integrity, and making sound regulatory compliance decisions when assessing and mitigating risks. Experience in vendor management of outsourced regulatory operations work. Demonstrated success streamlining document preparation across all internal functions as well as with external vendors, with a focus on opportunities for process improvement. Understanding of US regulations and guidelines pertaining to electronic records and signatures and eCTD standards. Possesses a solid foundation of regulatory knowledge and drug development experience, so as to be able to access, apply and interpret regulatory information. Knowledge of and ability to interpret scientific data, as it relates to regulatory requirements. Strong organizational and time-management skills, with ability to work to timelines and meet project milestones. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
01/27/2021
Full time
Job Title: Senior Manager Regulatory Operations Location: Cambridge, MA Type: Full Time, Salaried with Benefits Start Date: Immediate Global Pharmaceutical Company is looking to add a Senior Manger of Regulatory Operations to their team! Responsibilities: Ensures the creation of high-quality regulatory submission packages that meet company requirements along with regulatory agency electronic submission requirements and guidelines, ensuring timely delivery to health agencies Serves as primary interface between internal staff and external vendors, coordinates regulatory meetings and oversees the scheduling and coordinated completion of publishing deliverables. Responsible for development of submission plans, with content timelines and workflow tracking. Ensures organization and maintenance of Health Authority correspondence and regulatory information files. Contributes to the evaluation, testing and implementation of regulatory tools, technology for dossier management, publishing, archiving and submission. Monitors the development of new regulatory requirements or guidances and advises on the impact to the business. Identifies potential risks, developing mitigation plans for resolution of risk factors, along with status and escalation planning. Contributes to development and implementation of regulatory standards and procedures for dossier management, publishing, archiving and submission processes. Advises Clinical Development on products that are in-development, collaborating cross-functionally on preparation and submission of regulatory filings. May be required to perform other duties, as assigned. Requirements : BS degree is required, preferably in the life sciences A minimum of six to eight years of regulatory experience in the pharmaceutical industry, which includes four to six years of managing multiple projects in regulatory operations. Knowledge of drug development and the necessary support operations, and the associated regulatory requirements. Success in regulatory planning, dossier generation, publishing, and submission of all US dossiers; NDA/BLA experience is highly desirable. Demonstrated record of business integrity, and making sound regulatory compliance decisions when assessing and mitigating risks. Experience in vendor management of outsourced regulatory operations work. Demonstrated success streamlining document preparation across all internal functions as well as with external vendors, with a focus on opportunities for process improvement. Understanding of US regulations and guidelines pertaining to electronic records and signatures and eCTD standards. Possesses a solid foundation of regulatory knowledge and drug development experience, so as to be able to access, apply and interpret regulatory information. Knowledge of and ability to interpret scientific data, as it relates to regulatory requirements. Strong organizational and time-management skills, with ability to work to timelines and meet project milestones. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Title: Senior Validation Specialist Location: Warren, NJ Start date: ASAP Responsibilities: The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Through this work, the incumbent supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will be heavily involved with deviations, investigations and change controls. Implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures. Schedules and performs periodic review of validated computer systems Conducts investigations into qualification failures, develops and implements remediation plans Initiates, guides and reviews written procedures for calibration and preventive maintenance of common equipment and stand-alone computerized systems Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques. Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity. Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates. Reviews calibration, qualification and validation documentation for accuracy, completeness and compliance to the company standards. Provides technical knowledge and direction as Equipment Commissioning and Qualification site representative during interactions with all cross functional groups, as required. Promotes and provides excellent customer service and support. Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests. Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment. Promotes and maintains compliance with corporate, safety and regulatory policies. Maintains all required Corporate, Facilities and EHS training as required Champions adherence to and improvement of all safety procedures and hazard communication Requirements: BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent 7 years of combined experience in FDA-regulated GMP lab environment Must have experience validating and using common lab equipment and stand-alone computerized lab systems Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas. Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems Strong experience writing and executing system validation & equipment qualification documents Ability to interact effectively with laboratory personnel, QA, and Facilities groups Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation Innate ability to learn new software as required for equipment qualification and system validations. Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
01/21/2021
Full time
Title: Senior Validation Specialist Location: Warren, NJ Start date: ASAP Responsibilities: The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Through this work, the incumbent supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will be heavily involved with deviations, investigations and change controls. Implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures. Schedules and performs periodic review of validated computer systems Conducts investigations into qualification failures, develops and implements remediation plans Initiates, guides and reviews written procedures for calibration and preventive maintenance of common equipment and stand-alone computerized systems Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques. Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity. Manages laboratory systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates. Reviews calibration, qualification and validation documentation for accuracy, completeness and compliance to the company standards. Provides technical knowledge and direction as Equipment Commissioning and Qualification site representative during interactions with all cross functional groups, as required. Promotes and provides excellent customer service and support. Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests. Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met. Maintains a positive relationship with all the members of the Equipment Commissioning and Qualification department and site customers while promoting a positive team environment. Promotes and maintains compliance with corporate, safety and regulatory policies. Maintains all required Corporate, Facilities and EHS training as required Champions adherence to and improvement of all safety procedures and hazard communication Requirements: BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent 7 years of combined experience in FDA-regulated GMP lab environment Must have experience validating and using common lab equipment and stand-alone computerized lab systems Must have experience qualifying manufacturing facilities, utilities, common equipment, temperature-controlled chambers, and GMP storage areas. Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry Advanced knowledge of 21 CFR Part 11 compliance and Data Integrity requirements Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities, utilities, and manufacturing systems Strong experience writing and executing system validation & equipment qualification documents Ability to interact effectively with laboratory personnel, QA, and Facilities groups Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation Innate ability to learn new software as required for equipment qualification and system validations. Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Job Title: Regulatory Affairs Specialist II Location: Rockville, MD Start Date: Immediate This position is responsible for coordinating and preparing document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Will support senior Regulatory Affairs / CMC Regulatory Affairs staff working with development partner companies by facilitating regulatory activities to support company-sponsored clinical trials including responding to document requests. In addition, this role will be responsible for providing regulatory support for internal audits and inspections and maintaining departmental files and databases. Responsibilities and Job Duties Identifies the appropriate process to follow based on the scope of the submission and then compiles all materials required in submissions. Coordinates and prepares regulatory documents needed for annual reports, new investigators, SUSARs, internal audits and inspections, and other related requests. Ensures documents and all materials are complete and meet all submission requirements and timelines. Reviews site regulatory packages for clinical trial sites participating in sponsored clinical trials, as per company SOPs and Work Practices. Raises concerns and issues to senior RA team members. Updates departmental and company databases, e.g., master commitment tracker, 1572 reports, Trial Master Files. Organize and maintain hard copy and electronic department files and monitors and improves tracking/control systems. Uploads Health Authority communications into electronic document management system. When appropriate, recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Assists with regulatory intelligence activities and keeps abreast of regulatory procedures and changes, shares new information with team and trains stakeholders if necessary. Minimum Qualifications BA/BS or equivalent in a related field of study Two years of experience in a similar role in Regulatory Affairs in the pharmaceutical industry Ability to work in a scientific and technical-oriented environment Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner Must possess ability to handle multiple priorities in a fast-paced environment Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical submission-related issues)
01/18/2021
Full time
Job Title: Regulatory Affairs Specialist II Location: Rockville, MD Start Date: Immediate This position is responsible for coordinating and preparing document packages for regulatory submissions to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Will support senior Regulatory Affairs / CMC Regulatory Affairs staff working with development partner companies by facilitating regulatory activities to support company-sponsored clinical trials including responding to document requests. In addition, this role will be responsible for providing regulatory support for internal audits and inspections and maintaining departmental files and databases. Responsibilities and Job Duties Identifies the appropriate process to follow based on the scope of the submission and then compiles all materials required in submissions. Coordinates and prepares regulatory documents needed for annual reports, new investigators, SUSARs, internal audits and inspections, and other related requests. Ensures documents and all materials are complete and meet all submission requirements and timelines. Reviews site regulatory packages for clinical trial sites participating in sponsored clinical trials, as per company SOPs and Work Practices. Raises concerns and issues to senior RA team members. Updates departmental and company databases, e.g., master commitment tracker, 1572 reports, Trial Master Files. Organize and maintain hard copy and electronic department files and monitors and improves tracking/control systems. Uploads Health Authority communications into electronic document management system. When appropriate, recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Assists with regulatory intelligence activities and keeps abreast of regulatory procedures and changes, shares new information with team and trains stakeholders if necessary. Minimum Qualifications BA/BS or equivalent in a related field of study Two years of experience in a similar role in Regulatory Affairs in the pharmaceutical industry Ability to work in a scientific and technical-oriented environment Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner Must possess ability to handle multiple priorities in a fast-paced environment Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical submission-related issues)
Title: Project Specialist - Scientific - II Location: West Point, PA Start date: ASAP Responsibilities: Under the direction of the Laboratory Scheduling Associate Director, gather data for implementing a new Laboratory Planning and Scheduling tool. This position requires strong collaboration with supervisors in the eight Testing Laboratories to collect testing assay operational data to develop and implement the new system. The Associate Director has generated a Project Plan for the overall execution and the Laboratory Planning and Scheduling Associate will gather the details required for the plan and help execution by interacting with the Laboratory Operations personnel. This will be an office based project management position. Requirements: Bachelor of Science in Biology, Chemistry, Engineering or equivalent. Strong interpersonal skills to effectively collaborate with Laboratory Teams. Organized Project Management / Coordinator skills. Proficiency with Excel and other MS Office tools. Preferred: Science/Engineering Research or Project experience is an added plus. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
01/17/2021
Full time
Title: Project Specialist - Scientific - II Location: West Point, PA Start date: ASAP Responsibilities: Under the direction of the Laboratory Scheduling Associate Director, gather data for implementing a new Laboratory Planning and Scheduling tool. This position requires strong collaboration with supervisors in the eight Testing Laboratories to collect testing assay operational data to develop and implement the new system. The Associate Director has generated a Project Plan for the overall execution and the Laboratory Planning and Scheduling Associate will gather the details required for the plan and help execution by interacting with the Laboratory Operations personnel. This will be an office based project management position. Requirements: Bachelor of Science in Biology, Chemistry, Engineering or equivalent. Strong interpersonal skills to effectively collaborate with Laboratory Teams. Organized Project Management / Coordinator skills. Proficiency with Excel and other MS Office tools. Preferred: Science/Engineering Research or Project experience is an added plus. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
Administrative Assistant I Atlanta, GA 30339 System One is actively seeking an Administrative Assistant for a contract position located in Atlanta, GA. Administrative Assistant Responsibilities: Greet visitors, coordinate meeting space, assist with expense reports, receive/send packages and mail, and other duties as assigned The receptionist will be the point of contact for visitors (very few expected) Administrative Assistant Requirements: High School Diploma M-F, 40 hours Duration : Contract Location : Atlanta, GA Pay Rate : $20.00/hr
01/16/2021
Full time
Administrative Assistant I Atlanta, GA 30339 System One is actively seeking an Administrative Assistant for a contract position located in Atlanta, GA. Administrative Assistant Responsibilities: Greet visitors, coordinate meeting space, assist with expense reports, receive/send packages and mail, and other duties as assigned The receptionist will be the point of contact for visitors (very few expected) Administrative Assistant Requirements: High School Diploma M-F, 40 hours Duration : Contract Location : Atlanta, GA Pay Rate : $20.00/hr
Administrative Assistant System one is actively seeking an Administrative Assistant for a remote contract position. Administrative Assistant Requirements: - Quiet space to conduct business - Broadband/DSL internet connection with the ability to hard wire connect through an ethernet cord - Safeco provides all equipment needed, the only things not provided are a desk and a chair - Workstation in home should have the space needed for two 24 inch monitors and a desktop computer- Company will provide Equipment Administrative Assistant Requirements: In addition to the duties of a Receptionist: Type correspondence, reports, lists and tabulations. Edit grammar, spelling, punctuation, and document structure. Update calendar/schedule for manager. Coordinate manager's appointments, travel arrangements and meetings. Schedule facilities. Research and resolve problems. Aide manager in more complex tasks. Maintains logs, records and filing systems. Phone and mail duties. In addition to the skills of a Receptionist: Three years of office experience or equivalent relevant experience; Mature and responsible personality; Proficient in Microsoft Word, Excel, PowerPoint and Outlook. Duration: Contract Location : Remote Pay $15.00 per hour Hours: 9:00 AM -5:00 PM- Must be flexible
01/16/2021
Full time
Administrative Assistant System one is actively seeking an Administrative Assistant for a remote contract position. Administrative Assistant Requirements: - Quiet space to conduct business - Broadband/DSL internet connection with the ability to hard wire connect through an ethernet cord - Safeco provides all equipment needed, the only things not provided are a desk and a chair - Workstation in home should have the space needed for two 24 inch monitors and a desktop computer- Company will provide Equipment Administrative Assistant Requirements: In addition to the duties of a Receptionist: Type correspondence, reports, lists and tabulations. Edit grammar, spelling, punctuation, and document structure. Update calendar/schedule for manager. Coordinate manager's appointments, travel arrangements and meetings. Schedule facilities. Research and resolve problems. Aide manager in more complex tasks. Maintains logs, records and filing systems. Phone and mail duties. In addition to the skills of a Receptionist: Three years of office experience or equivalent relevant experience; Mature and responsible personality; Proficient in Microsoft Word, Excel, PowerPoint and Outlook. Duration: Contract Location : Remote Pay $15.00 per hour Hours: 9:00 AM -5:00 PM- Must be flexible
Title: Regulatory Affairs Specialist - III Location: Camden, NJ Start date: ASAP Responsibilities: Regulatory Analyst with emphasis on ingredients. This role advises the R&D, global procurement and businesses on the safe use, regulatory compliance and labeling of food ingredients. This includes reviewing all ingredients purchased by the company, with consideration of how they are manufactured and how they are intended to be used from a regulatory perspective. Evaluate new ingredients and technologies for regulatory compliance against applicable US and Canadian food regulations. Provide input to ingredient specifications in a way that assures ongoing regulatory and internal compliance. Determine labeling terms to be used for finished products with consideration of business needs for transparency Respond to internal and external customer inquiries regarding use and function of ingredients Resolve regulatory questions with suppliers during the ingredient and formula review process so that business and Quality needs are addressed prior to approval and use. Work closely with Campbell Toxicologist to oversee externally contracted safety evaluations for ingredients to support technical, marketing and regulatory and/or nutrition-related initiatives. Gather regulatory and nutrition-related ingredient information for use in product information databases or as part of corporate social responsibility indices. Manage documentation to preserve integrity of files needed to substantiate labeling with regulatory agencies. Requirements: B.S. food science, nutrition, chemistry or related OR M.S. food science, nutrition, chemistry or related 3+ years' experience with food ingredients and formulations in an industry or government setting General knowledge of the regulatory landscape (e.g., regulations, issues) that may affect the food industry. This includes knowledge of the major regulatory issues facing the industry. Participate on internal regional and global cross-functional teams working on innovation across the entire portfolio, and provide input and guidance to minimize scientific and regulatory barriers. Familiarity with common food formulations and manufacturing processes. Ability to manage projects to ensure successful delivery (on time, within budget, meeting agreed upon success criteria) to establish clear goals and accountabilities. Advise and educate internal stakeholders by disseminating key facts and presenting complex information in a concise and easy-to-understand manner. Use technical and business expertise to explain difficult concepts to technical and non-technical audiences, tailoring communications to meet each. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
01/14/2021
Full time
Title: Regulatory Affairs Specialist - III Location: Camden, NJ Start date: ASAP Responsibilities: Regulatory Analyst with emphasis on ingredients. This role advises the R&D, global procurement and businesses on the safe use, regulatory compliance and labeling of food ingredients. This includes reviewing all ingredients purchased by the company, with consideration of how they are manufactured and how they are intended to be used from a regulatory perspective. Evaluate new ingredients and technologies for regulatory compliance against applicable US and Canadian food regulations. Provide input to ingredient specifications in a way that assures ongoing regulatory and internal compliance. Determine labeling terms to be used for finished products with consideration of business needs for transparency Respond to internal and external customer inquiries regarding use and function of ingredients Resolve regulatory questions with suppliers during the ingredient and formula review process so that business and Quality needs are addressed prior to approval and use. Work closely with Campbell Toxicologist to oversee externally contracted safety evaluations for ingredients to support technical, marketing and regulatory and/or nutrition-related initiatives. Gather regulatory and nutrition-related ingredient information for use in product information databases or as part of corporate social responsibility indices. Manage documentation to preserve integrity of files needed to substantiate labeling with regulatory agencies. Requirements: B.S. food science, nutrition, chemistry or related OR M.S. food science, nutrition, chemistry or related 3+ years' experience with food ingredients and formulations in an industry or government setting General knowledge of the regulatory landscape (e.g., regulations, issues) that may affect the food industry. This includes knowledge of the major regulatory issues facing the industry. Participate on internal regional and global cross-functional teams working on innovation across the entire portfolio, and provide input and guidance to minimize scientific and regulatory barriers. Familiarity with common food formulations and manufacturing processes. Ability to manage projects to ensure successful delivery (on time, within budget, meeting agreed upon success criteria) to establish clear goals and accountabilities. Advise and educate internal stakeholders by disseminating key facts and presenting complex information in a concise and easy-to-understand manner. Use technical and business expertise to explain difficult concepts to technical and non-technical audiences, tailoring communications to meet each. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
