Quality Assurance Specialist (External Filling)

What You’ll Do
- Review and approve executed batch records from external drug product filling sites.
- Review and approve master batch records from external drug product filling sites.
- Represent Quality Assurance in support of complex Deviations, Change Controls, CAPAs, including active participation in investigations and problem resolution.
- Liaise with external partners to communicate QA policies/procedures and provide input on regulatory communications.
- Train and/or mentor junior employees on processes and procedures.
- Provide QA-aligned consultation and advice.
- Support disposition of raw materials and product (receipt, inspection, document review, shipping) on the floor or at a desk.
- Review, edit, or approve controlled Regeneron documents.
- Participate in investigations involving raw materials or product.
- Perform status labeling of product.
- Continually evaluate processes and procedures for continuous improvement.

Let’s Find Out If We’re a Fit
- B.S. in life sciences or related field (may substitute proven experience).
- Quality Assurance Specialist: 4+ years’ experience.
- Senior Quality Assurance Specialist: 6+ years’ experience.

Benefits
- Student loan paydown program & tuition reimbursement.
- Family care benefits.
- Relocation assistance.
- Inclusion, culture and well-being programs (including physical & mental health).

#REGNQA
- Apply now.