QA Batch Release Specialist – Quality & Compliance

Sanofi; Pocono Township (PA); On-site; USD 69,000 - 100,000; Full time

Job summary

Sanofi in Swiftwater, PA is seeking a QA Release specialist to ensure product quality through batch release processes. The role supports review of batch records, LRPs, ESUM, and environmental monitoring, ensuring compliance with GMP and regulatory requirements and timely release of materials.

The candidate will perform quality reviews, disposition of batches, and collaboration with QA leadership to drive improvements and maintain schedules.

Qualifications

• Bachelor’s degree is required.
• 1+ years of experience in a GMP-controlled pharmaceutical environment.

Responsibilities

• Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA 21 CFR, and applicable health authority regulations.
• Complete all required system transactions associated with the batch record review process.
• Provide data for PDR manufacturing dates and Commodity Verification Sheets for further processing of material.
• Review Certificate of Analysis/Conformance to verify all required testing has been performed and meets requirements prior to batch disposition.
• Act as delegate to the QA Release Lead to approve shipment to external manufacturers when assigned.

Skills

Batch record review

GMP compliance

Data analysis

Project management

Education

Bachelor's degree

Tools

Microsoft Excel

PowerPoint

Microsoft Word

Job description

Sanofi in Swiftwater, PA is seeking a QA Release specialist to ensure product quality through batch release processes. The role supports review of batch records, LRPs, ESUM, and environmental monitoring, ensuring compliance with GMP and regulatory requirements and timely release of materials.

The candidate will perform quality reviews, disposition of batches, and collaboration with QA leadership to drive improvements and maintain schedules.