Quality Assurance Auditor - cGMP Compliance

Regulatory Toolkit; Pennsylvania; On-site; USD 59,000 - 85,000; Full time

Job summary

Sanofi Inc. in Swiftwater, PA seeks a Quality Assurance Specialist to uphold cGMP compliance across manufacturing, testing and distribution. You will lead audits, investigations, and CAPA activities, and provide regulatory-aligned recommendations to improve processes and procedures.

You will ensure audit readiness, support change control, and sign off on SOPs and Master Manufacturing Records, collaborating with production and QA teams to protect patients and maintain product quality.

Qualifications

• Bachelor's degree in a relevant field.
• 3+ years of quality experience in a GMP-regulated environment.
• Experience conducting audits, investigations, and CAPA.

Responsibilities

• Maintain audit readiness across production and testing areas.
• Perform cGMP audits and identify deficiencies.
• Lead CAPA investigations and corrective actions.
• Support Change Control and SOP reviews.
• Provide final sign-off on SOPs and Master Manufacturing Records.
• Communicate with regulators and internal teams.

Skills

QA Experience

Regulatory Knowledge

Auditing

Investigations

Education

Bachelor's Degree

Job description

Sanofi Inc. in Swiftwater, PA seeks a Quality Assurance Specialist to uphold cGMP compliance across manufacturing, testing and distribution. You will lead audits, investigations, and CAPA activities, and provide regulatory-aligned recommendations to improve processes and procedures.

You will ensure audit readiness, support change control, and sign off on SOPs and Master Manufacturing Records, collaborating with production and QA teams to protect patients and maintain product quality.