Affinity Executive Search

LOVE YOUR JOB! Our client is a global, multibillion dollar firm with offices near Atlanta. Atlanta, as we all know, is famed for its high quality of life and reasonable cost of living. Our client is offering a competitive salary, benefits, great work environment, relocation assistance, a great work/life balance, and continued career growth opportunity. They are seeking a SENIOR SOX INTERNAL AUDITOR who will * perform professional internal auditing work, supervise and report on the results of audits * be a key component of the success in providing internal audit services * conduct performance, financial, information systems, fraud and compliance audit projects * provide consulting services to the organizations management and staff * give input to development of the annual audit plan * be under limited supervision with moderate latitude for initiative and independent judgment. This is a focused corporate growth opportunity with THE global industry leader in its multi-billion dollar global industry. It comes with a comfortable, modern work environment where there is a strong team atmosphere. If you're looking to devlop and grow your career within audit, accounting & finance, or other corporate areas this company WILL present you with serious opportunities! REQUIREMENTS: * Degree * 4+ years of full-time experience in auditing, accounting or business analysis. * Strong SOX requirements knowledge and experience REQUIRED. * CIA or CPA REQUIRED. * Knowledge of and skill in applying internal auditing and accounting principles and practices, and management principles and preferred business practices. * Knowledge of the Standards for the Professional Practice of Internal Auditing and the Code of Ethics developed by The Institute of Internal Auditors. * Knowledge of industry program policies, procedures, regulations and laws. * Skill in effective verbal and written communications, including active listening skills and skill in presenting findings and recommendations. * Ability to establish and maintain harmonious working relationships with co-workers, staff and external contacts, and to work effectively in a professional team environment. * Ability to travel (up to 30%). #LI-SK1

POSITION SUMMARY: QC Micro IlI must have broad knowledge of all the techniques within the laboratory required for the routine support of the microbiology laboratory operations. In this role the Analyst will be a fully functional member of the team responsible for testing, data entry and occasional review of data for finished product, in-process samples, stability samples, clinical materials and raw material release in a cGMP regulated environment MAJORRESPONSIBILITIES: * Execution of microbiological tests including but not limited to bioburden, LAL, growth promotion, sterility, particulate profiling and microbial identification of bulk, raw materials, in-process material, components, clinical materials and finished product * If required, must be able to perform cGMP biological testing (bioassays, flow cytometry, qPCR, and ELISA) * Review and data entry for testing results following GMP regulations into the electronic data management systems * Perform laboratory investigations for out of specification and/or out of trend results * Write change controls and work orders for systems and instrumentation changes * Creation/Revision of SOPs, and other documents required to support testing and ensure compliance * Participate in non-routine projects, validations and method development to meet departmental and individual goals * The employee will be required to participate in an on call schedule for various shift, holiday, or weekend work as needed. PREFERRED QUALIFICATIONS: * Experience with the execution of test methods for sterile and non-sterile drug products, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters * Critical thinker, ability to identify issues and work quickly to bring resolution * Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor * Understand common microbiological test instrumentation * Excellent organizational, planning and scheduling skills * Good verbal and written communication skills * Experience of Thermo Sample Manager LIMS or other applicable LIMS systems The successful employee will have the ability to function in a microbiological laboratory environment; the employee should have no inhibitions regarding safely handling microorganisms present in the * laboratory, aseptic gowning, and no health conditions that would prevent them from doing so * Optional:Hands on experience in flow cytometry, quantitative PCR, and other bioanalytical methods like ELISA is an added advantage EDUCATION AND EXPERIENCE: * Bachelors in science, preferably in Biology / Microbiology / Biotechnology or Biochemistry, required * 3+ yearexperience in pharmaceutical manufacturing or contract testinglaboratory required

REPORT TO: ENGINEERING MANAGER THE SUPERINTENDENT PLANT PROCESS / CHEMICAL IS A NEW POSITION FOR THIS PLANT START-UP. PRIMARY PURPOSE OF POSITION: Responsible for leading chemical process team and driving plant process optimization for the chemical and wastewater treatment area of a high volume, 24/7 manufacturing facility. ESSENTIAL FUNCTIONS: * Lead and develop team members and manage resources, activities, and vendors to assure efficient operations for the chemical process area. * Establishes, documents, monitors and improves maintenance procedures on equipment. * Uses data to diagnose problem areas and leads team through development and implementation of corrective action plans. * Drives a culture of root cause analysis and continuous improvement. * Establishes and maintains effective work relationships within the department, manufacturing process areas and the overall plant. * Recognizes waste streams and minimizes waste generation. Complies with safety procedures and environmental regulations when using, dispensing and handling hazardous and non-hazardous materials and wastes. * Working knowledge of areas including, but not limited to: * Acid washers, hazardous and non-hazardous chemicals, metal forming lubrication systems, wastewater treatment systems, and deionized water and water softening systems. * Production processes, product specifications and technology of equipment. SUPERVISION: Supervise from 4 to 8 Personnel

This is a full-time, permanent Supervisor of Quality Control Quality Assurance career opportunity at constantly growing, state-of-the-art industry leader in the custom food packaging industry. This position is open due to growth. Employees are treated so well that they had four employees retire this year with over fifty years of service. The culture has a family feel and employees can move to other departments, if that is of interest. Duties and responsibilities of the successful candidate are as follows: * Overseeing quality * Planning and assigning work to direct reports * Managing, training and motivating direct reports * Communicating with a variety of people * Writing reports * Achieving an HACCP certification Candidates will have a minimum background consisting of the following: * Four or more years of quality control / quality assurance experience * Two or more years of effectively managing quality employees * Ability to oversee accurate laboratory data analysis * A degree

Opportunity for BCBA Board Certified Behavior Analyst (ABA - BCBA) JOB DESCRIPTION: As Applied Behavior Analysis Board Certified Behavior Analysis, employee is responsible for overseeing clinical treatment of DSM-5 and ICD-10 Related Disorders, Including both mental health and medical conditions which will benefit from Applied Behavior Analysis (ABA) as treatment for related conditions. In addition to guiding clinical treatment, BCBA is responsible for providing clinical treatment, detailing and creating treatment plans as well as Individualized Service Plans (ISPs), providing supervision and training for Registered Behavior Technicians and Behavior Technicians, Data Analysis, Intake Assessment and other duties as guided and needed under the direction of Program Director. CLINICAL SUPPORT: Provide 1:1 treatment as needed for clients in service Provide parent education and support as needed and required in services Develop, maintain, and implement individualized treatment plans/behavior support plans/master treatment plans for clients in services Provide clinical supervision for Behavior Technicians/Registered Behavior Technicians providing ABA to clients in service Provide as needed training and staff development to Behavior Technicians/Registered Behavior Technicians Provide on site supervision to Behavior Technicians/Registered Behavior Technicians as needed/required by private, commercial, or state regulated insurance Maintain, develop, and provide and deliver treatment plans to families in services Maintain ongoing data collection of service objectives for families in services Analyze and update data as related to treatment goals, objectives, and interventions as related to families/clients in services EDUCATION AND EXPERIENCE: Minimum of Masters Degree in human service related field (Education, Psychology, Social Work, Etc.) with 1 year supervisory experience with Board Certification and Licensure in applicable state(s) PREFERRED QUALIFICATIONS: 3 Years Supervisory Experience Providing Behavior Analysis, Data Analysis, Supervision of Behavior Technicians, and Providing Clinical Behavior Treatment and Treatment Planning

THIS IS A TECHNICAL SALES/MANAGEMENT ROLE THAT REQUIRES EXPERIENCE IN AUTOMATION/ELECTRICAL PRODUCTS OR SERVICES: An Automation/Electrical Distributor is looking for the right person to lead their sales team in their office in Kansas City, KS. You will be proud to represent this company who has been in business for over 60 years and is a leader in the industry. As Branch Manager (Automation Distributor) you will be responsible for the sales growth at this location. In this role, you will provide direction to salespeople as well as generate sales of your own. RESPONSIBILITIES: * Provide overall leadership, motivation, direction, and coordination for all salespeople. * Provide coaching and development of sales staff by identifying and implementing strategies to improve performance * Work with Operations to analyze and adjust inventory to maximize capital efficiency, while ensuring proper support of customers * Develop and implement financial and non-financial objectives, including annual sales goals and expense budgets * Make decisions based on what is best for the company to grow * Manage a specific customer base EXPERIENCE AND QUALIFICATIONS: * Bachelors degree and/or 10+ years of experience in industrial distribution * Proven record as a successful salesperson, selling to MRO, OEM, system integrator, and contractor accounts * Demonstrated track record of achieving results * Working knowledge of budgets, forecasting, and metrics * Excellent organizational skills * Ability to effectively present information to all levels of the company * Excellent interpersonal skills, including coaching, team-building, and training skills

Software Quality Engineer Will support new product development activities, maintain compliance to company procedures and external standards, manage design history files, build verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation, support creation of 510k packages, conduct failure\problem investigations, identify system issues, summarize findings and prepare reports for key quality metrics. Responsibilities also include being the quality and compliance representative in the assigned teams. * Responsible for being the prime quality representative for design control projects new product development as well as sustaining efforts. * Responsible for review and/or approval of design history file documentation in support of design controls. * Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory, compliance and product security support. * Writes and/or leads risk management activities including risk management reports and risk analyses. * Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release. * Works together with SW Quality Engineers to ensure effective verification of design specifications and/or requirements. * Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.). * Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design improvements. * Active participant in the development of product requirement, product system hazard analysis and design reviews. * Work closely with Product Management to ensure effective validation of user needs. * Ensure product technical files and Design History Files are complete and audit-able. * Provide clarification and mentorship to teams on overall quality system with emphasis in design controls. * Conducts audits as member of a quality system audit team (e.g. SME, etc.) * Track record of root cause determination and effective corrective / preventive action implementation. * Provides decisions, recommendations, and results to foster the achievement of goals critical to organizational objectives. * Identifies areas requiring quality improvement and initiates and follows through plans of action (Quality Plans) vital for implementation. * Quality lead in 510k or International submissions. * Mentor to Quality Engineers on approach to design controls, agile design, risk management and product security. When applicable, have the ability to lead quality engineers. Requirements * Bachelors degree in engineering or life sciences. * 10+ years related experience in design and development. * ASQ certified (CQA, CQE, CSQE, CMQ) is a definite plus * Must be able to apply quality principles (ISO 13485, IEC 62304, 21 CFR, etc.) to the R&D environment * In-depth knowledge of software development life cycle and test methodology. * Experience dealing with Software products highly desired

This position reports directly to the Quality Manager. SPECIFIC JOB DUTIES: * Customer quality responsibilities * Training of operators in standardized processes * Coordinate dimensional evaluations * Complete capability study * Audit/document quality systems * Problem solve assembly issues * Work closely with manufacturing team members as well as interact directly with suppliers and customers * Assist in maintaining LPA process * Troubleshoot quality issues with the Operations and Technical department * Root cause analysis through fast track response process * Assist in the development and mentoring of the Quality techs * Support Quality Manager in daily functions as needed * Audit internal process to ensure they meet TS/ISO Standards * Responsible for the creation, maintenance, and validation of CMM programs used for the measurements of manufactured and supplied parts using PC DMIS+CAD software/ Polyworks. * Read and interpret GD&T to determine dimensions and tolerance specifications. * Prepare sample submissions (PPAP) to include final product inspection on PPAP, Engineering, Production Trial Run, and other samples. * Assist Process Engineer/Technical Group with qualification and validation of new or changed tooling, fixtures, and parts. * Analyze inspection reports to determine adherence to drawings, specifications, and to troubleshoot failure mode. * Assist and support manufacturing/production personnel with various inspection activities. * Ensure Gauge Calibration is carried out according to ISO/TS16949 standards. * Maintenance of laboratory equipment and CMM Chuck Fixtures EDUCATION REQUIREMENTS * Bachelor degree with 2-4 years of related experience or 3-5 years related experience in a quality manufacturing environment, automotive preferred. EXPERIENCE REQUIREMENTS * Good computer skills including typing and the use of Microsoft products * 1 year or more CMM programming and/or operating experience * Conceptual knowledge of production part approval process (PPAP) and relevant requirements preferred * Working knowledge of SPC, capability studies, PFMEAs, and Control Plans * Ability to pay attention to detail, multi-task and follow direction * Successful candidates will also possess strong judgment /decision making skills, problem solving and communication skills. * Strong analytic problem solving skills * Able to work well under pressure while managing competing demands and tight deadlines * Must be able to work with minimal supervision

Responsible for leading the implementation/training/support for Sage V9/V12 Supply Chain/Sales and distribution modules. This includes in-depth participation and conducting of the business requirements review, inclusive of full leadership of the business requirement document deliverable. * Responsible for deliverables at every phase of ERP implementation lifecycle * Documenting the process flows and communicating best practices for the to-be optimal state. * Adapting the solution for localizations or business processes specific to business unit. * Communicate and coordinate the project status with internal and external key stakeholders. * Developing a test strategy to validate the solution and confirming successful deployment. * Identifying risks or issues associated with assigned tasks, taking initiative to proactively alert project leadership of any risks or issues. * Be willing to learn, research and adapt to new technologies and methodologies Opportunity to be the right hand man/woman to the hiring manager who is the Head of IT in a pharmaceutical company. Seeking somebody who can take ownership of the process. The client has a lenient policy on remote. Any ERP experience will be sufficient, so if you dont have SAGE experience but other ERP experience then it could still be a great fit... REQUIREMENTS: Required Knowledge, Skills and Abilities * B.A or equivalent in computer/data science / business management / Logistics * Minimum 3 of years experience in ERP support or ERP consulting * 3+ years experience working with ERP software (SAP , Microsoft Dynamix , Sage etc) . * Supply Chain edge to edge flows * Manufacturing and planning background and methodologies MRP/MPS * Excellent written and oral communication skills * Experience with implementing end-to-end ERP projects * Excellent written and oral communication skills * Project management skills Preferred Knowledge, Skills and Abilities * Consulting background * Data analytics and queries SQL/PLSQL/EXCEL/BI * Programming script writer * Working Experience in Chemical/Process manufacturer * Sage X3 V9 or V12 ERP

PROCESS ENGINEER - PLASTICS LOCATION: Lake Zurich, IL COMPENSATION: Commensurate with experience. ABOUT THE COMPANY: * Dynamic design and manufacturing company with headquarters in the Greater Chicago, IL area. * Expertise in metals and plastics serving the Automotive Industry. * Global company with a presence in the USA, Canada, Mexico and China. * Environment that is constantly growing and improving throughout their 50 year history. JOB DESCRIPTION SUMMARY: The Process Engineer will be responsible for development and documentation of process parameters for new and existing molds. Creates process parameters, specifications, establishes manufacturing control plans to improve quality. DUTIES AND RESPONSIBILITIES: * This individual will interface directly with R&D, Manufacturing and external vendors to resolve manufacturing issues in process, machine, and/or tooling. * Develop optimum processes for new and existing molds * Recommends/implement improvements to molds and equipment * Provides processing expertise and guidance to Supervisors * Mandates a working and functional knowledge of the plastic injection molding process, tooling, equipment and materials. * Facilitate engineering support for injection molding. * Suggest part design and/or tool modifications to improve part performance and moldability. * Review, critique and approve mold designs by vendors. * Launches new molds, equipment and manufacturing lines. * Perform tool and process capability studies. * Trains molding and set-up personnel. * Review tooling condition and develop appropriate expense and capital budget. * Research and develop new manufacturing processes. * Analyze manufacturing data and suggest/implement improvements. * Analyze production and machinery line. * Interact with customers, suppliers, and internal resources. * Establish the parameters for an optimal molding environment. * Analyze quality control and correct flaws. * Work with other team members and vendors. * Create validation process documentations, including water and schematic drawings * Oversees and assesses existing processes and workflows. * Provides thorough instructions for successful implementation of process changes. * Conducts risk assessments. * Contributes to departmental efforts by accomplishing related tasks as needed * Ability to set, start and sample new tooling * Participation and utilization in the companys commitment to continuous improvement. * Follow ISO/IATF, safety, and environmental procedures as well as department and corporate policies and procedures. JOB KNOWLEDGE; SKILLS AND ABILITIES: * Excellent analytical and math skills * Strong written and verbal communication skills * Ability to persuade others to change existing practices * Strong attention to detail * Proven ability to identify, assess and solve problems * Proficient with computer and information technology * Knowledge of process engineering EDUCATION AND TRAINING: * Previous experience in process engineering * Previous experience working with CAD and AutoCAD * 5 years of progressive injection molding or engineering experience. * CAD and Solid works experience and Six Sigma experience are a plus but not required. * Paulson Training * De-coupled molding training RJG TOOLS AND EQUIPMENT: * Computer and other general office equipment. * Steel toed shoes, safety glasses and ear plugs where required. Keywords: Plastic Injection Molding, AutoCAD, SolidWorks, Six Sigma, Continuous Improvement, Process Engineer, RJG Training _(The duties listed above are intended only as illustrations of the various types of work that may be performed. Other duties may be assigned are not limited to the following listed above)_ HOW TO EXPRESS INTEREST - CLICK THE APPLY BUTTON AND FOLLOW THE ONLINE INSTRUCTIONS.

A successful and established company who manufactures systems that treat and purify water for municipalities and a variety of industries is looking for a PROJECT ENGINEER with a CHEMICAL ENGINEERING degree to design and manage challenging water treatment applications. In business for 50 years and each project is different so your work stays fresh. No need for casual Fridays... because they make every effort to provide a relaxed and fun environment. Plus they understand the importance or work/life balance and offer great benefits. DUTIES AND RESPONSIBILITIES: * Designs, specifies and interprets P&IDs, BOMs and O&Ms * Provides submittal and start-up support * Completes required bids and proposals * Designs and conducts operational tests * Reads and interprets blueprints, technical drawings, schematics and reports * Provide engineering support * Occasional travel (less than 10%) Qualifications: * BS in CHEMICAL ENGINEERING * 2-5 years related experience * Experience with AutoCAD * Experience with designing piping systems (2+ years) * Ability to perform calculations needed for drawing creation * Excellent verbal and written communication skills * Excel, Word, Adobe Word Processing software WHY WORK HERE: * Competitive salary with great benefits package * Casual work environment * Open door policy with administration * Low travel required. (less than 10%)