External Manufacturing Compliance Specialist - GMP

Regeneron Pharmaceuticals, Inc.; United States; Presencial; USD 62.000 - 129.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Compliance Specialist to support External Manufacturing operations in East Greenbush, NY. The role focuses on ensuring cGMP compliance, maintaining procedures, and preparing for inspections, while driving continuous improvement.

The position requires knowledge of FDA/ICH regulations, experience with CMOs/CROs, and strong writing and communication skills. On-site work schedule is Monday–Friday, 8am–4:30pm.

Formación

• BS/BA in scientific field required with cGMP operations experience.
• Knowledge of regulatory compliance (cGMP, FDA, ICH, EU).
• Experience with CMOs/CROs preferred.
• Strong written and verbal communication skills.

Responsabilidades

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures and other documents with a focus on continuous improvement.
• Maintain knowledge of current good manufacturing practices (cGMPs).
• Support internal and external inspection and audit readiness activities.
• Perform periodic reviews of Drug Product Manufacturing documentation for compliance with quality standards.

Conocimientos

Interpersonal skills

Communication skills

Technical writing

Adaptability

Team collaboration

Educación

BS/BA in scientific field

Herramientas

Veeva

Opstrakker

Excel

PowerPoint

Visio

Word

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Compliance Specialist to support External Manufacturing operations in East Greenbush, NY. The role focuses on ensuring cGMP compliance, maintaining procedures, and preparing for inspections, while driving continuous improvement.

The position requires knowledge of FDA/ICH regulations, experience with CMOs/CROs, and strong writing and communication skills. On-site work schedule is Monday–Friday, 8am–4:30pm.