QA Specialist: Batch Records & Product Disposition

Regeneron; New York (NY); On-site; USD 62,000 - 110,000; Full time

Job summary

Regeneron seeks a Quality Assurance Specialist for the batch record and disposition team in East Greenbush, NY. The role ensures product disposition per QA policies, cGMPs, and SOPs, with responsibilities spanning investigations, document reviews, and external collaboration.

Ideal candidates have 4+ years of QA experience in life sciences. On-site role with some domestic travel and a typical 8am–4:30pm schedule, with salary range disclosed.

Qualifications

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

Responsibilities

• Represent QA in support of deviations, change controls, CAPAs, and investigations.
• Represent QA with external partners to communicate QA policy and procedures.
• Provide consultation in alignment with QA policies.
• Dispostion of product, including document review and disposition packs.
• Review, edit, or approve Regeneron controlled documents.
• Review investigations related to raw materials, product, labs, facilities.
• Contribute to continuous improvement of Regeneron processes and procedures.
• May train or mentor junior employees on QA processes.

Skills

QA

CAPA

Deviation investigation

Documentation review

Education

B.S in life sciences or related field

Job description

Regeneron seeks a Quality Assurance Specialist for the batch record and disposition team in East Greenbush, NY. The role ensures product disposition per QA policies, cGMPs, and SOPs, with responsibilities spanning investigations, document reviews, and external collaboration.

Ideal candidates have 4+ years of QA experience in life sciences. On-site role with some domestic travel and a typical 8am–4:30pm schedule, with salary range disclosed.