cGMP Compliance Specialist - Process Sciences

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality Records Specialist within the Process Sciences department in the United States.

You will oversee cGMP quality records, drive change controls, CAPAs, and supplier notifications, acting as a Subject Matter Expert for quality systems and record integrity. You will train staff in technical writing and quality awareness, maintain key metrics, and coordinate changes across departments to ensure compliant documentation and proactive regulatory

Qualifications

• BS/BA in scientific discipline or related field with 0-2+ years industry experience for Associate level.
• BS/BA in scientific discipline or related field with 2+ years industry experience for Intermediate level.
• BS/BA in scientific discipline or related field with 5+ years industry experience for Senior level.

Responsibilities

• Execute, monitor, and track progress of Process Sciences quality records (Change controls, supplier notifications, CAPAs).
• Serve as SME for quality records and systems, ensuring record consistency.
• Train and promote technical writing and quality awareness across the team.

Skills

Quality systems

CAPA management

Change controls

Technical writing

Cross-functional communication

Education

Assoc: BS/BA in scientific discipline

Int: BS/BA in scientific discipline

Sr: BS/BA in scientific discipline

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Quality Records Specialist within the Process Sciences department in the United States.

You will oversee cGMP quality records, drive change controls, CAPAs, and supplier notifications, acting as a Subject Matter Expert for quality systems and record integrity. You will train staff in technical writing and quality awareness, maintain key metrics, and coordinate changes across departments to ensure compliant documentation and proactive regulatory