What are the responsibilities and job description for the Senior Quality Assurance Associate position at Joulé?
Title: Senior Quality Assurance Associate
Location: Devens, MA
Type: 6-month contract
Pay rate: 50/hour
Overview:
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:
Requirements:
Ref: #558-Scientific
Location: Devens, MA
Type: 6-month contract
Pay rate: 50/hour
Overview:
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
Requirements:
- BS in a scientific field with 5–7 years, or MS with 3–5 years in an FDA-regulated industry
- Minimum 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
- 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
