QA Auditor - cGMP, CAPA & Compliance Lead

Sanofi Group; Pennsylvania; Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

Sanofi Inc. is seeking a Quality Assurance Specialist in Swiftwater, PA to ensure compliance with cGMP, regulatory, and internal standards through audits, investigations, and process improvements.

The role supports production, testing, and distribution to safeguard patient safety and product quality. Key functions include maintaining inspection readiness, executing QA activities across aseptic and manufacturing areas, and driving CAPA initiatives.

Qualifications

• Bachelor's degree required in a relevant field.
• 3+ years quality experience preferred in a GMP regulated environment.
• Experience with QA audits, investigations, and CAPA processes is desirable.

Responsabilités

• Maintain inspection readiness and address audit observations on time.
• Support production and testing to ensure cGMP compliance across areas.
• Conduct cGMP audits and communicate deficiencies to management.
• Lead investigations for incidents/out-of-spec results and drive CAPA actions.
• Assist Change Control processes with assessments and documentation.
• Provide final sign-off on SOPs, SWIs, and Master Manufacturing Records.

Connaissances

GMP knowledge

Audit readiness

Documentation

Data analysis

Communication

Formation

Bachelor's Degree

Description du poste

Sanofi Inc. is seeking a Quality Assurance Specialist in Swiftwater, PA to ensure compliance with cGMP, regulatory, and internal standards through audits, investigations, and process improvements.

The role supports production, testing, and distribution to safeguard patient safety and product quality. Key functions include maintaining inspection readiness, executing QA activities across aseptic and manufacturing areas, and driving CAPA initiatives.