• Senior Quality Assurance Associate

    System One (Devens, MA)


    Title: Senior Quality Assurance Associate

     

    Type: 6 month contract

     

    Pay rate: 50/hr

     

    The organization is seeking experienced Sr. QA Associates to support Quality Assurance operations for clinical and commercial Active Pharmaceutical Ingredients (APIs). This role will involve floor support, batch review and release, and investigation activities to ensure strict compliance with GMP standards and regulatory expectations.

    Key Responsibilities:

    + Perform GMP walkthroughs and provide QA floor support to Manufacturing and QC

    + Lead and document investigations: deviations, OOT/OOS, CAPAs

    + Review and approve executed batch records; support lot disposition

    + Participate in internal audits, FDA inspections, and client audits

    + Support quality systems, document control, and SOP management

    + Mentor QA team members and contribute to continuous improvement initiatives

    + Writing Deviations based on investigation findings

    Qualifications:

    + Education: BS in a scientific field with 5–7 years, or MS with 3–5 years in an FDA-regulated industry

    + Experience:

    + 7+ years in GMP QA roles within life sciences

    + Strong background in CAPAs, deviation investigations, FDA audits, and document control

    + Experience with APIs, clinical and commercial manufacturing

    + Proficiency with GMP, ICH Q7, 21 CFR Part 11, ALCOA+ principles

    + Skills:

    + Strong technical writing and communication

    + Detail-oriented, problem-solving mindset

     

    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

     

    Ref: #558-Scientific

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.