Process Sciences Quality & Compliance Specialist

Regeneron Pharmaceuticals, Inc; Town of East Greenbush (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Sciences quality role to oversee cGMP compliance. The position will manage quality records, serve as a SME for quality systems, and promote training and awareness across teams.

Responsibilities include tracking CAPAs, change controls, and supplier notifications; communicating metrics; and coordinating changes with other departments. On-site position with competitive rewards in the U.S.

Qualifications

• Assoc: BS/BA in scientific discipline or related field with 0-2+ years industry experience; or equivalent combination of education and experience.
• Int: BS/BA in scientific discipline or related field with 2+ years industry experience; or equivalent combination of education and experience.
• Sr: BS/BA in scientific discipline or related field with 5+ years industry experience; or equivalent combination of education and experience.

Responsibilities

• Execute, monitor, and track progress of Process Sciences owned quality records, such as Change controls, supplier notifications and CAPAs.
• Be a SME for quality records and quality systems, ensuring consistency of records.
• Train and promote technical writing and quality awareness.
• Maintain and communicate appropriate metrics.
• Review department owned quality records for compliance and accuracy.
• Strong communicator to represent Process Sciences at daily & weekly cross functional meetings.
• Act as a liaison for coordination of changes between the Process Sciences department and other departments.
• Drive proactive compliance environment in the Process Sciences department through knowledge transfer and education of compliance related items.

Education

Assoc: BS/BA in scientific discipline or related field

Int: BS/BA in scientific discipline or related field

Sr: BS/BA in scientific discipline or related field with 5+ years industry experience

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Process Sciences quality role to oversee cGMP compliance. The position will manage quality records, serve as a SME for quality systems, and promote training and awareness across teams.

Responsibilities include tracking CAPAs, change controls, and supplier notifications; communicating metrics; and coordinating changes with other departments. On-site position with competitive rewards in the U.S.