Quality Assurance Consultant (CMC)
Bedford, MA
Job Type: Contract | Recruiter: Hillary Bergstrom | Phone: 603-772-2700
Location: Bedford, MA (Hybrid – 2 to 3 days onsite)
Length: 12+ months
Job Description:
Our client is seeking a highly skilled and experienced Quality Assurance (QA) Consultant to join their team. This role requires expertise in quality assurance for cGMP manufacturing processes. The ideal candidate will have a strong background in reviewing Manufacturing Batch Production Records and managing quality systems.
Essential Duties and Responsibilities (but not limited to):
- Provide quality expertise in the review of cGMP Manufacturing Batch Production Records, including Cell Banks, Viral Banks, Plasmids, Drug Substance, Drug Product, and Finished Product.
- Coordinate the timely resolution of comments related to batch production record reviews.
- Review and approve manufacturing-associated deviations and change controls.
- Offer onsite support at the manufacturing plant by reviewing and approving quality systems records.
- Contribute to various QA projects and objectives as needed.
- Bachelor's Degree with at least 8+ years of relevant experience in a cGMP environment.
- Prior experience in a GxP biotechnology or pharmaceutical environment is essential (gene therapy experience is preferred).
- Extensive experience in Batch Record Review.
- Solid background in handling change controls and deviations is essential.
- Ability to work effectively and collaboratively with external CMOs and internal cross-functional teams.
- Flexibility to adapt to a fast-paced environment with shifting priorities.
- Strong organizational, collaboration, and attention to detail skills.
- Effective communication abilities in a multi-functional team setting.
Make this your next career move as one of our many long-term contractors or employees!
- Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
- Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.
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