Job Description

Position: Quality Assurance Consultant (CMC)

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.

Qualifications:

• 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.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

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.

Come see why DPC has achieved:

• 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.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

Job #17380

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