QA Compliance Specialist: cGMP & Audit Expert

Sanofi; Swiftwater (Monroe County); On-site; USD 60,000 - 90,000; Full time

Job summary

Sanofi is seeking a Quality Assurance Specialist in Swiftwater, PA to ensure cGMP compliance across manufacturing, testing, and distribution. The role emphasizes audits, investigations, and CAPA to drive process improvements and regulatory readiness.

You will support aseptic operations, risk assessments, and change controls while interacting with cross-functional teams to ensure patient safety and product quality. A Bachelor's degree and GMP experience are preferred.

Qualifications

• Bachelor’s degree in a relevant field.
• 3+ years of quality experience in GMP environment.
• Experience performing QA audits and CAPA activities.
• Strong data analysis to identify trends and issues.
• Excellent verbal and written communication.
• Ability to manage multiple projects in a regulated setting.

Responsibilities

• Maintain audit readiness and close observations on time.
• Provide floor coverage for production, development, and testing QA.
• Perform parallel and CCA sampling as required.
• Conduct cGMP audits and communicate deficiencies to management.
• Lead CAPA system to implement corrective actions.
• Support Change Control assessments and documentation.
• Review SOPs, SWIs, and Master Manufacturing Records for compliance.

Skills

Quality assurance

Audits

CAPA

Data analysis

Communication

Project management

Education

Bachelor's Degree

Job description

Sanofi is seeking a Quality Assurance Specialist in Swiftwater, PA to ensure cGMP compliance across manufacturing, testing, and distribution. The role emphasizes audits, investigations, and CAPA to drive process improvements and regulatory readiness.

You will support aseptic operations, risk assessments, and change controls while interacting with cross-functional teams to ensure patient safety and product quality. A Bachelor's degree and GMP experience are preferred.