External Manufacturing Compliance Specialist

Regeneron Pharmaceuticals, Inc (USA); New York (NY); Vor Ort; USD 62.000 - 129.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Compliance Specialist for the External Manufacturing team in East Greenbush, NY. This role focuses on operations support and compliance activities for Regeneron product manufacturing.

The candidate will lead change controls, SCARs, CAPAs, and reviews of cGMP documentation, contributing to audit readiness and continuous improvement. A BS in a scientific field with cGMP experience is preferred.

Qualifikationen

• BS/BA in scientific field with cGMP manufacturing experience.
• Knowledge of drug product manufacturing from formulation through final package.
• Regulatory compliance knowledge incl. cGMP, FDA, ICH, EU.
• Proficient in Veeva, Opstrakker, Office suite.
• Strong interpersonal and written/oral communication.

Aufgaben

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
• Maintain knowledge of current good manufacturing practices (cGMPs).
• Support both internal and external inspection and audit readiness activities.
• Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
• Maintain required training status on Regeneron specific work instructions and SOPs.
• Continuous process improvement implementation.

Kenntnisse

cGMP

Veeva

Excel

Regulatory compliance

Documentation handling

Communication skills

CMOs/CROs collaboration

Ausbildung

BS/BA in scientific field

Tools

Veeva

Opstrakker

Excel

PowerPoint

Visio

Word

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking a Compliance Specialist for the External Manufacturing team in East Greenbush, NY. This role focuses on operations support and compliance activities for Regeneron product manufacturing.

The candidate will lead change controls, SCARs, CAPAs, and reviews of cGMP documentation, contributing to audit readiness and continuous improvement. A BS in a scientific field with cGMP experience is preferred.