Title: Senior Quality Assurance Associate 
Location: Devens, MA
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, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.