University Enterprises, Inc.
Sacramento, California
The Office of Water Programs (OWP) is a research and training organization located on the Sac State campus. The OWP Research Group is seeking Environmental Specialists I and II . The OWP Research Group provides technical expertise and applied research services in water quality monitoring and evaluation, stormwater permits and best management practices (BMPs), water and wastewater treatment, and water resources. OWP provides an excellent opportunity to work in an entrepreneurial, collaborative manner with a small, highly proficient group of professionals on projects that require innovative solutions. As a self-supporting entity, OWP obtains its funding from contracts and competitive grants. Past clients include California state agencies including Caltrans, State Water Resources Control Board, Department of Water Resources, Office of Emergency Services, Department of Toxic Substances Control, and Department of Parks and Recreation. Other clients and partnerships have included environmental consulting firms, equipment manufacturers, and the California Stormwater Quality Association. OWP has successfully competed for state and federal grant funds. Recent grants include a $10M award to provide drinking water technical assistance to disadvantaged communities in California and a $4.9M award to develop a program that allows licensed child care centers in California to sign up for free lead testing of their drinking water and free replacement of contaminated drinking water fixtures. OWP, through an EPA grant, is the EPA Region 9 Environmental Finance Center (EFC). As the EFC and through a state grant program, OWP provides water, wastewater, and groundwater technical assistance to disadvantaged communities. OWP also teamed on a grant project with the City of Sacramento to implement and test low impact development devices on the Sac State campus. Technical services we provide through contracts/grants include stormwater management program planning and implementation; hydrologic and hydraulic modelling; flood inundation mapping; lab-scale testing; planning, design, and management of field-scale experiments; analysis and interpretation of monitoring data; stormwater training and testing; geographic information systems (GIS) and other computerized modeling; project management; and information dissemination. To be considered, apply by Friday, September 17, 2021. We encourage you to apply to the position that best suits your qualifications. Environmental Specialist I $4,854 - $5,329 per month Environmental Specialist II $5,483 - $8,224 per month University Enterprises, Inc. (UEI) offers an excellent benefits package that includes: • Participation in CalPERS Retirement Program • Paid Vacation Time - starting at 10 hours accrued/month • Paid Sick Time - 8 hours accrued/month • Paid Holidays - 13 paid holidays per year including paid time off the week between Christmas Day and New Year's Day as the CSUS campus is closed plus one personal day. • Excellent medical benefits - 100% employer paid medical & dental for employee-only coverage and low cost for family coverage Position Overview The Environmental Specialists series, with progressive levels of responsibility, provides support and advice services for applied research and technical assistance projects conducted by the Office of Water Programs on environmental problems. This position includes water quality and water resources specialties. The position involves providing technical expertise for stormwater compliance programs; technical assistance to disadvantaged communities; planning and construction of experimental facilities; planning, administering, and conducting research activities; and disseminating research results. This position assists with proposals, marketing, planning, organizing, supervising, and/or performing the work of a professional staff, and ensures that work products meet OWP quality standards. The position represents OWP at professional meetings and conferences involving state and federal entities, Sacramento State and other colleges/universities, industry, and private sector organizations. This position reports directly and receives general direction from the Associate Director of Research for the Office of Water Programs or their designee. DUTIES AND RESPONSIBILITIES Environmental Specialist I Provides advice in designing, implementing, and completing research projects. Collects, analyzes and interprets field and laboratory data from stormwater characterization research projects, stormwater runoff toxicity evaluations, Total Maximum Daily Load (TMDL) studies, and similar projects. Provides technical expertise and support for stormwater compliance programs. Identifies the need and assists in incorporating research findings in design and implementation of environmental and water resources projects. Administers research and technical assistance projects, including preparation of selected contract documents (e.g., scopes and schedules), day-to-day contract enforcement, and evaluation of project results. Prepares reports and presentations of findings to university, contractor, and other interested parties and groups. Provides Quality Assurance/Quality Control (QA/QC) for sample collection and reporting activities. Participates in conferences and workshops to transmit research results. Additional duties for Environmental Specialist II Assists in the preparation of proposals. MINIMUM QUALIFICATIONS Environmental Specialist I Bachelor of Science Degree in biological sciences, biology, microbiology, chemistry, geology, earth sciences, environmental sciences or related field. Excellent oral and written communication skills. Demonstrated ability to interpret and analyze environmental laws and regulations including Federal Register and Code of Federal Regulations (CFR). Demonstrated knowledge of the characteristics and environmental impacts of point and non-point source pollution. Demonstrated ability to work in a multidisciplinary research group. Demonstrated ability to review and edit technical project reports and documents. Demonstrated ability to present information and results in conferences and meetings. Must be legally eligible to drive in California, complete and pass an online training course, maintain a good driving record, and be acceptable for vehicle insurance coverage under the University Enterprises insurance plan. Must continue to meet the established driving standards. Driving record will be monitored with the California Department of Motor Vehicles to ensure compliance. Must pass a background check, which may include fingerprinting. Must continue to meet the established standards. Additional qualifications for Environmental Specialist II Master of Science Degree in biological sciences, biology, microbiology, chemistry, geology, earth sciences, environmental sciences or related field. Demonstrated knowledge of monitoring and analysis of natural and engineered environmental systems. recblid skow21ckbrbjy99xow5rirazmsr50d
09/22/2021
Full time
The Office of Water Programs (OWP) is a research and training organization located on the Sac State campus. The OWP Research Group is seeking Environmental Specialists I and II . The OWP Research Group provides technical expertise and applied research services in water quality monitoring and evaluation, stormwater permits and best management practices (BMPs), water and wastewater treatment, and water resources. OWP provides an excellent opportunity to work in an entrepreneurial, collaborative manner with a small, highly proficient group of professionals on projects that require innovative solutions. As a self-supporting entity, OWP obtains its funding from contracts and competitive grants. Past clients include California state agencies including Caltrans, State Water Resources Control Board, Department of Water Resources, Office of Emergency Services, Department of Toxic Substances Control, and Department of Parks and Recreation. Other clients and partnerships have included environmental consulting firms, equipment manufacturers, and the California Stormwater Quality Association. OWP has successfully competed for state and federal grant funds. Recent grants include a $10M award to provide drinking water technical assistance to disadvantaged communities in California and a $4.9M award to develop a program that allows licensed child care centers in California to sign up for free lead testing of their drinking water and free replacement of contaminated drinking water fixtures. OWP, through an EPA grant, is the EPA Region 9 Environmental Finance Center (EFC). As the EFC and through a state grant program, OWP provides water, wastewater, and groundwater technical assistance to disadvantaged communities. OWP also teamed on a grant project with the City of Sacramento to implement and test low impact development devices on the Sac State campus. Technical services we provide through contracts/grants include stormwater management program planning and implementation; hydrologic and hydraulic modelling; flood inundation mapping; lab-scale testing; planning, design, and management of field-scale experiments; analysis and interpretation of monitoring data; stormwater training and testing; geographic information systems (GIS) and other computerized modeling; project management; and information dissemination. To be considered, apply by Friday, September 17, 2021. We encourage you to apply to the position that best suits your qualifications. Environmental Specialist I $4,854 - $5,329 per month Environmental Specialist II $5,483 - $8,224 per month University Enterprises, Inc. (UEI) offers an excellent benefits package that includes: • Participation in CalPERS Retirement Program • Paid Vacation Time - starting at 10 hours accrued/month • Paid Sick Time - 8 hours accrued/month • Paid Holidays - 13 paid holidays per year including paid time off the week between Christmas Day and New Year's Day as the CSUS campus is closed plus one personal day. • Excellent medical benefits - 100% employer paid medical & dental for employee-only coverage and low cost for family coverage Position Overview The Environmental Specialists series, with progressive levels of responsibility, provides support and advice services for applied research and technical assistance projects conducted by the Office of Water Programs on environmental problems. This position includes water quality and water resources specialties. The position involves providing technical expertise for stormwater compliance programs; technical assistance to disadvantaged communities; planning and construction of experimental facilities; planning, administering, and conducting research activities; and disseminating research results. This position assists with proposals, marketing, planning, organizing, supervising, and/or performing the work of a professional staff, and ensures that work products meet OWP quality standards. The position represents OWP at professional meetings and conferences involving state and federal entities, Sacramento State and other colleges/universities, industry, and private sector organizations. This position reports directly and receives general direction from the Associate Director of Research for the Office of Water Programs or their designee. DUTIES AND RESPONSIBILITIES Environmental Specialist I Provides advice in designing, implementing, and completing research projects. Collects, analyzes and interprets field and laboratory data from stormwater characterization research projects, stormwater runoff toxicity evaluations, Total Maximum Daily Load (TMDL) studies, and similar projects. Provides technical expertise and support for stormwater compliance programs. Identifies the need and assists in incorporating research findings in design and implementation of environmental and water resources projects. Administers research and technical assistance projects, including preparation of selected contract documents (e.g., scopes and schedules), day-to-day contract enforcement, and evaluation of project results. Prepares reports and presentations of findings to university, contractor, and other interested parties and groups. Provides Quality Assurance/Quality Control (QA/QC) for sample collection and reporting activities. Participates in conferences and workshops to transmit research results. Additional duties for Environmental Specialist II Assists in the preparation of proposals. MINIMUM QUALIFICATIONS Environmental Specialist I Bachelor of Science Degree in biological sciences, biology, microbiology, chemistry, geology, earth sciences, environmental sciences or related field. Excellent oral and written communication skills. Demonstrated ability to interpret and analyze environmental laws and regulations including Federal Register and Code of Federal Regulations (CFR). Demonstrated knowledge of the characteristics and environmental impacts of point and non-point source pollution. Demonstrated ability to work in a multidisciplinary research group. Demonstrated ability to review and edit technical project reports and documents. Demonstrated ability to present information and results in conferences and meetings. Must be legally eligible to drive in California, complete and pass an online training course, maintain a good driving record, and be acceptable for vehicle insurance coverage under the University Enterprises insurance plan. Must continue to meet the established driving standards. Driving record will be monitored with the California Department of Motor Vehicles to ensure compliance. Must pass a background check, which may include fingerprinting. Must continue to meet the established standards. Additional qualifications for Environmental Specialist II Master of Science Degree in biological sciences, biology, microbiology, chemistry, geology, earth sciences, environmental sciences or related field. Demonstrated knowledge of monitoring and analysis of natural and engineered environmental systems. recblid skow21ckbrbjy99xow5rirazmsr50d
State Street Corporation
Burlington, Massachusetts
Sr. Product Specialist/QA (EMS Trading Team) - Charles River Development Summary: Work as a member of a Scrum team leading the overall quality planning and execution for one of Charles River's products. Provide support and assistance to customers, team members, and other teams within Charles River. Responsibilities: Work closely with the Scrum Master, Product Owner, developers, business analysts and other project team members to assist in carrying out the software quality responsibilities of the Scrum team Create comprehensive test plans with well defined, reusable test cases from business requirements and functional specifications documents Execute manual and automated functional, integration, regression, and performance tests Maintain automated and manual test script libraries for functional, integration, regression, and performance testing Document software defects in the issue tracking system and proactively communicate issues with developers and other project team members Provide testing leadership by identifying opportunities for improvement in the Scrum team's QA methodology Adhere to a testing schedule to ensure efficient and effective product delivery Actively participate in the Agile software development process by adhering to the CRD Scrum methodology including attending all daily standups, sprint planning, backlog grooming, and retrospectives Participate in group testing activities as needed Guide and mentor junior staff in proper creation and planning of test processes Education: B.S. degree (or foreign education equivalent) in Computer Science, Engineering, Mathematics, and Physics or other technical course of study or Business with an MIS background. MS degree strongly preferred. Experience: 4 - 7 years of experience in software testing in a process driven technology environment Demonstrated experience using test cases, scripts, and automated test tools for verifying requirements on multi-tier applications Demonstrated ability translating business requirements into comprehensive functional and technical test plans Knowledgeable in one or more CRD functional areas strongly desired A minimum of 3 years working with an Agile development methodology strongly desired Effective written and verbal communication
01/31/2021
Full time
Sr. Product Specialist/QA (EMS Trading Team) - Charles River Development Summary: Work as a member of a Scrum team leading the overall quality planning and execution for one of Charles River's products. Provide support and assistance to customers, team members, and other teams within Charles River. Responsibilities: Work closely with the Scrum Master, Product Owner, developers, business analysts and other project team members to assist in carrying out the software quality responsibilities of the Scrum team Create comprehensive test plans with well defined, reusable test cases from business requirements and functional specifications documents Execute manual and automated functional, integration, regression, and performance tests Maintain automated and manual test script libraries for functional, integration, regression, and performance testing Document software defects in the issue tracking system and proactively communicate issues with developers and other project team members Provide testing leadership by identifying opportunities for improvement in the Scrum team's QA methodology Adhere to a testing schedule to ensure efficient and effective product delivery Actively participate in the Agile software development process by adhering to the CRD Scrum methodology including attending all daily standups, sprint planning, backlog grooming, and retrospectives Participate in group testing activities as needed Guide and mentor junior staff in proper creation and planning of test processes Education: B.S. degree (or foreign education equivalent) in Computer Science, Engineering, Mathematics, and Physics or other technical course of study or Business with an MIS background. MS degree strongly preferred. Experience: 4 - 7 years of experience in software testing in a process driven technology environment Demonstrated experience using test cases, scripts, and automated test tools for verifying requirements on multi-tier applications Demonstrated ability translating business requirements into comprehensive functional and technical test plans Knowledgeable in one or more CRD functional areas strongly desired A minimum of 3 years working with an Agile development methodology strongly desired Effective written and verbal communication
JOB TITLE: Sr.QA Specialist Location:New Brunswick,NJ Duration:11 months contract JOB DESCRIPTION: Coordinate, develop, and manage a robust process relating to material qualification and certification for the network. Execute and improve network procedures for Client's sites globally. This may requires revisions to procedures for managerial review and approval and drafts documentation where appropriate. Train on multiple procedures/processes, and provide support to a wider spectrum of stakeholders in the network. SME in multiple aspects of documentation and supplier quality management (i.e. vendor management, supplier scorecard, quality agreements, approved supplier list, material qualification, reduce testing, etc.) Knowledgeable of laboratory reduce testing and material qualification. Primary resource for material qualification and certification support. Support supplier investigations and trending as needed. Act as Quality lead on assigned projects. Skilled in writing, reviewing supplier quality agreements and master supplier agreements Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, chemistry, supply chain, a related discipline, or the equivalent in related experience. 4-7 years of experience in Supplier Quality, cGMP Biologics QC laboratory or related cGLP or cGMP environment. Proficiency (or mastery) of methodologies within QC (i.e. reduce testing, qualification, etc.) and supplier quality (i.e. investigation, non-conformances, corrective actions, agreements, etc.) Attention to detail and demonstrated organizational skills. Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. Proficiency in applying cGMP regulations and compendial testing required. Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices. Demonstrates leadership, and independent problem solving and analytical thinking skills. Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, ELN, Maximo or similar, DeltaV or similar, and Infinity or similar. Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QA/QC in order to exchange information regarding supplier quality and reduce testing as it relates to meeting department goals and objectives Daily contact with her/his manager for work assignments. Routine contact with manager for coaching and general performance management discussions. Occasional contact with other management staff relating to specific project responsibilities may be expected. May represent Quality in cross functional teams or projects. Cross-site/vendor communications as needed for strategic purposes May be required to coordinate with site stakeholders for troubleshooting purposes relating to suppliers. Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing, laboratory, and/or project timeline Flexibility to work irregular hours and short notice overtime. Sr. Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions. Incumbents normally receive little to no instructions on routine work and assist with the creation of detailed instructions on new assignments. May be expected to lead cross-functional project team. Sr. Specialist will be expected to participate in the training of less experienced personnel as well as assisting less experienced personnel in normal operational tasks.
01/16/2021
Full time
JOB TITLE: Sr.QA Specialist Location:New Brunswick,NJ Duration:11 months contract JOB DESCRIPTION: Coordinate, develop, and manage a robust process relating to material qualification and certification for the network. Execute and improve network procedures for Client's sites globally. This may requires revisions to procedures for managerial review and approval and drafts documentation where appropriate. Train on multiple procedures/processes, and provide support to a wider spectrum of stakeholders in the network. SME in multiple aspects of documentation and supplier quality management (i.e. vendor management, supplier scorecard, quality agreements, approved supplier list, material qualification, reduce testing, etc.) Knowledgeable of laboratory reduce testing and material qualification. Primary resource for material qualification and certification support. Support supplier investigations and trending as needed. Act as Quality lead on assigned projects. Skilled in writing, reviewing supplier quality agreements and master supplier agreements Knowledge of science generally attained through studies resulting in a BS in the physical or life sciences, chemistry, supply chain, a related discipline, or the equivalent in related experience. 4-7 years of experience in Supplier Quality, cGMP Biologics QC laboratory or related cGLP or cGMP environment. Proficiency (or mastery) of methodologies within QC (i.e. reduce testing, qualification, etc.) and supplier quality (i.e. investigation, non-conformances, corrective actions, agreements, etc.) Attention to detail and demonstrated organizational skills. Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints. Proficiency in applying cGMP regulations and compendial testing required. Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices. Demonstrates leadership, and independent problem solving and analytical thinking skills. Proficiency with common computer software applications (email, MS Office, etc.) and lab based computer applications LIMS, ELN, Maximo or similar, DeltaV or similar, and Infinity or similar. Will work in teams and have continual interaction with members of his/her team as well as other sub-teams within QA/QC in order to exchange information regarding supplier quality and reduce testing as it relates to meeting department goals and objectives Daily contact with her/his manager for work assignments. Routine contact with manager for coaching and general performance management discussions. Occasional contact with other management staff relating to specific project responsibilities may be expected. May represent Quality in cross functional teams or projects. Cross-site/vendor communications as needed for strategic purposes May be required to coordinate with site stakeholders for troubleshooting purposes relating to suppliers. Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing, laboratory, and/or project timeline Flexibility to work irregular hours and short notice overtime. Sr. Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending and implementing corrective actions. Incumbents normally receive little to no instructions on routine work and assist with the creation of detailed instructions on new assignments. May be expected to lead cross-functional project team. Sr. Specialist will be expected to participate in the training of less experienced personnel as well as assisting less experienced personnel in normal operational tasks.
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
01/15/2021
Full time
Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Senior Director, Process Excellence & Standards will set strategy and direction for the Process Excellence & Standards organization within Global Clinical Operations & Planning and play a key role in implementing and maintaining a continuous process improvement framework for the design and implementation of end-to-end clinical trial processes including rollout of a Process Council, kick-off of cross-functional Process Teams, and implementation of new roles (Process Owner and Process Manager/Specialist). Under the leadership of the Sr. Director, the Process Excellence & Standards group will also be responsible for developing process documentation and SOPs, GCP training and broader Learning and Development activities, metrics & benchmarking, and clinical quality management including tracking of GCP deviations/nonconformances, CAPA management, and inspection readiness. Responsibilities: Set strategy and direction for the Process Excellence & Standards Center of Excellence within Global Clinical Operations & Planning encompassing business process management, training, and clinical quality management Partner with functional leaders and Process Owners to shape and implement a continuous process improvement (CPI) framework for end-to-end clinical trial processes including rollout of Process Council, kick-off of Process Teams, and implementation of Process Owner and Process Manager/Specialist roles Serve as Chief of Staff for the Process Council, working with the committee chairs, members, and Process Teams to facilitate high-level governance of process improvement (strategy, prioritization, guidance, support and issue resolution) and maintenance of a continuous improvement plan for DS's portfolio of processes Establish a Process Owner/Process Manager forum to drive the change to CPI model and ensure consistency/connectivity across processes. In addition, keeps abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to processes and proactively initiates discussions and process changes Work with Process Managers and Metrics/Benchmarking lead to ensure that appropriate process performance metrics are maintained and actively deployed to diagnose and address process gaps/deficiencies Support the efforts of Process Owners/Process Managers to drive change management and implementation of major process design changes Partner with QA to ensure that clinical SOPs and GCP training are up-to-date, GCP deviations/nonconformances are tracked and addressed, and to ensure inspection readiness and CAPA management for items under GCO responsibility Shape training and development strategies of GCOP staff through deployment of a GCO training center of excellence Recruit, train, coach and develop staff to ensure development and deployment of key capabilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education/Experience: Bachelor's Degree with minimum of 10 years' experience in pharmaceutical or biotechnology drug development. Significant experience and expertise in end-to-end clinical trial processes including experience in one or more key functions (e.g., clinical research, clinical operations, data management, biostatistics, clinical QA) Understanding of industry trends (e.g., regulatory, technology) with ability to apply them to process improvements Strong leadership, collaboration, and influencing skills including team leadership or functional management Experience in clinical trial process design, harmonization/optimization, process implementation, and change management Knowledge and understanding of GCPs and applicable regulatory guidelines governing clinical trials and clinical quality management Experience with delivering presentations before executive staff Previous experience working in cross-functional study teams/ projects and/or ability to establish and manage relationships Effective and influential communication, self-management, problem solving and organizational skills Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Job Title Senior Director, Process Excellence & CRO Alliance Mgmt City Basking Ridge Functional Area Global Clinical Operations & Planning State New Jersey
Business Analyst (ETL Development experience) Location : Stamford, CT Duration : Long term Target Start Date : ASAP Required Skills: Gather Functional and Technical Business Requirements in BI and DW Expert SQL Skills Expert PL/SQL Skills Teradata ETL Development skills Participate in QA and UAT activities Thanks & Regards Srikanth Rao Moraparaju / Sr. Talent Acquisition Specialist | (w): - provided by Dice
10/02/2020
Full time
Business Analyst (ETL Development experience) Location : Stamford, CT Duration : Long term Target Start Date : ASAP Required Skills: Gather Functional and Technical Business Requirements in BI and DW Expert SQL Skills Expert PL/SQL Skills Teradata ETL Development skills Participate in QA and UAT activities Thanks & Regards Srikanth Rao Moraparaju / Sr. Talent Acquisition Specialist | (w): - provided by Dice
Apex Systems has an immediate need for PAR QA Analyst for one of our clients. This position will sit remote currently due to COVID for a client based out of Chesapeake and Fairfax VA. If you are interested in learning more about this role, please e-mail your resume to Shannon at Position: PAR QA Location- Remote due to COVID. Type: Contract to hire (6 months) *Based out of Chesapeake OR Fairfax , VA; applicants should be aware this role will eventually have a rotating remote schedule once safe to return to the office. (Personnel Action Request) PAR Quality Review staff apply their advanced skills and experience in processing end to end personnel data transactions. They apply demonstrated knowledge of the personnel data rules and regulations and technology. Job Responsibilities Conducting processed PAR audits for QC Identifying QA process improvements Administering quality review and process improvement activities; Performing personnel action request processing; Processing employee personnel data corrections; Maintaining applicant/employee records in HRIS; Inputting data into Human Resource Information Systems (HRIS); Minimum Qualifications 3-5 years of Federal PAR experience Experience interpreting and applying federal employee benefits laws, rule, regulations, policies, and procedures Attention to detail Process record audit experience Strong interpersonal skills Good oral and written communication Preferred Requirements Bachelor's degree Shared services experience EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice
09/28/2020
Full time
Apex Systems has an immediate need for PAR QA Analyst for one of our clients. This position will sit remote currently due to COVID for a client based out of Chesapeake and Fairfax VA. If you are interested in learning more about this role, please e-mail your resume to Shannon at Position: PAR QA Location- Remote due to COVID. Type: Contract to hire (6 months) *Based out of Chesapeake OR Fairfax , VA; applicants should be aware this role will eventually have a rotating remote schedule once safe to return to the office. (Personnel Action Request) PAR Quality Review staff apply their advanced skills and experience in processing end to end personnel data transactions. They apply demonstrated knowledge of the personnel data rules and regulations and technology. Job Responsibilities Conducting processed PAR audits for QC Identifying QA process improvements Administering quality review and process improvement activities; Performing personnel action request processing; Processing employee personnel data corrections; Maintaining applicant/employee records in HRIS; Inputting data into Human Resource Information Systems (HRIS); Minimum Qualifications 3-5 years of Federal PAR experience Experience interpreting and applying federal employee benefits laws, rule, regulations, policies, and procedures Attention to detail Process record audit experience Strong interpersonal skills Good oral and written communication Preferred Requirements Bachelor's degree Shared services experience EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or - provided by Dice
QA Specialist with Managerial experience (** Must have 3 to 5 years working in a medical device industry with FDA validation.) *w2 6+ month contract Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).maple Grove, MN 6+ The ideal candidate will possess the following qualifications: - At least 10 years working in QA expense, QA or validation management, with some managerial experience - Have worked on several large initiatives (more than 1 million budget) - Have at least 7 years of writing test cases in Quality Center and managing the testing and defects. - Ability to ensure proper test coverage from requirements - 3 to 5 years working in a medical device industry with FDA validation. - Ability to think on their feet, as well as ability to quickly take on issues - Knowledge of EPIQ reliance a plus - Ability to take direction or criticism if it is warranted - Be able to hit the ground running - there won't be much time for Mani to hand off - Needs to be a good communicator and team player - Of course a good personality helps, but more important if they are a good resource Additionally, candidates will also need: - Experience adding requirements to QC and appropriate linkage to test cases - Experience testing mobile applications - Ability to understand complex logic and apply appropriate testing - Write test cases based on risk level of requirements - Experience writing security role test cases Ability to apply comp - any standards and best practices, while also identifying areas for improvement - Developing a test plan for each software release cycle - Experience authoring test cases - 7+ years of writing cases in quality center, writing defects, testing management - Experience with FDA experience - Need someone that can hit the ground running - Strong communicator, Not afraid to ask questions, team player - Candidates need to be comfortable with waterfall - BA is required Top skills: - Medical device experience - software validation - Ability to develop a test plan from beginning to end - Someone that shows that they can work collaboratively BS degree or 3-7 years equivalent experience Saroj Ghosh, Sr. Technical Recruiter, Direct: "Making the world a better place, one job at a time - provided by Dice
09/28/2020
Full time
QA Specialist with Managerial experience (** Must have 3 to 5 years working in a medical device industry with FDA validation.) *w2 6+ month contract Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).maple Grove, MN 6+ The ideal candidate will possess the following qualifications: - At least 10 years working in QA expense, QA or validation management, with some managerial experience - Have worked on several large initiatives (more than 1 million budget) - Have at least 7 years of writing test cases in Quality Center and managing the testing and defects. - Ability to ensure proper test coverage from requirements - 3 to 5 years working in a medical device industry with FDA validation. - Ability to think on their feet, as well as ability to quickly take on issues - Knowledge of EPIQ reliance a plus - Ability to take direction or criticism if it is warranted - Be able to hit the ground running - there won't be much time for Mani to hand off - Needs to be a good communicator and team player - Of course a good personality helps, but more important if they are a good resource Additionally, candidates will also need: - Experience adding requirements to QC and appropriate linkage to test cases - Experience testing mobile applications - Ability to understand complex logic and apply appropriate testing - Write test cases based on risk level of requirements - Experience writing security role test cases Ability to apply comp - any standards and best practices, while also identifying areas for improvement - Developing a test plan for each software release cycle - Experience authoring test cases - 7+ years of writing cases in quality center, writing defects, testing management - Experience with FDA experience - Need someone that can hit the ground running - Strong communicator, Not afraid to ask questions, team player - Candidates need to be comfortable with waterfall - BA is required Top skills: - Medical device experience - software validation - Ability to develop a test plan from beginning to end - Someone that shows that they can work collaboratively BS degree or 3-7 years equivalent experience Saroj Ghosh, Sr. Technical Recruiter, Direct: "Making the world a better place, one job at a time - provided by Dice
