QA Batch Release Specialist – Quality & Compliance

Regulatory Jobs; Pennsylvania; On-site; USD 69,000 - 100,000; Full time

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Job summary

Sanofi is seeking a QA Release specialist at the Swiftwater site in Swiftwater, PA. You will perform final QA review of batch records, disposition decisions, and preparation/review of Lot Release Protocols to ensure products meet regulatory standards.

Role requires GMP experience and strong documentation skills. You will collaborate with QA teams to support on-time releases and compliance across manufacturing operations.

Qualifications

• Bachelor's degree in a relevant field and GMP knowledge.
• 1+ year of experience in a GMP-controlled pharmaceutical environment.
• Strong ability to review batch records and ensure regulatory compliance.

Responsibilities

• Perform final quality review of manufacturing records for accuracy and completeness per site procedures and regulatory requirements.
• Complete all required system transactions associated with batch record review and disposition processes.
• Provide data for production dates and verification sheets to support material release and traceability.
• Review certificates of analysis and conformance to verify testing has been performed and meets release criteria.
• Prepare and review Lot Release Protocols for regulatory submission and ensure GMP compliance.

Skills

Batch record review

Deviation investigation

Project management

MS Office proficiency

Education

Bachelor's degree

Tools

Microsoft Excel

PowerPoint

Word

Job description

Sanofi is seeking a QA Release specialist at the Swiftwater site in Swiftwater, PA. You will perform final QA review of batch records, disposition decisions, and preparation/review of Lot Release Protocols to ensure products meet regulatory standards.

Role requires GMP experience and strong documentation skills. You will collaborate with QA teams to support on-time releases and compliance across manufacturing operations.