QA Specialist: Batch Records & Disposition

Biopharma Careers; United States; On-site; USD 62,000 - 110,000; Full time

Job summary

Regeneron is seeking a Quality Assurance (QA) Specialist to join our batch record & disposition team, based in East Greenbush, NY. Work hours are 8:00 am–4:30 pm, with up to 10% travel domestically; most roles are on-site to support QA activities and investigations.

You will review and disposition products, manage change controls and CAPAs, and interact with external partners. Strong knowledge of cGMPs and QA policies is required, with 4+ years for senior levels.

Qualifications

• BS in life sciences or related field; may substitute proven experience for education requirement.
• 2+ years of experience for Associate QA Specialist
• 4+ years of experience for QA Specialist

Responsibilities

• Represent QA in support of deviations, change controls, CAPAs, and investigations; participate in problem resolution.
• Represent QA with external partners to communicate QA policy and liaise with external sites.
• Provide consultation in alignment with QA policies.
• Perform disposition activities including document review and COA review.
• Review and approve Regeneron controlled documents and QA investigations.
• Mentor junior team members and share process knowledge.

Skills

QA Experience

Documentation

GxP Knowledge

cGMPs

Education

BS Life Sciences

Job description

Regeneron is seeking a Quality Assurance (QA) Specialist to join our batch record & disposition team, based in East Greenbush, NY. Work hours are 8:00 am–4:30 pm, with up to 10% travel domestically; most roles are on-site to support QA activities and investigations.

You will review and disposition products, manage change controls and CAPAs, and interact with external partners. Strong knowledge of cGMPs and QA policies is required, with 4+ years for senior levels.