QA Release

Job title: QA Release

Location: Swiftwater, PA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

This is a 2nd shift position covering either Tuesday-Saturday or Sunday-Thursday

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Meet department safety, quality, productivity, and cost targets and goals in a compliant and timely manner

•  Act as Trainer for QA Release activities. 

• Review Specification Checklist, Certificate of Analysis (and Conformance) to verify all required testing has been performed and all testing meets requirements prior to batch disposition. 

• Verify the lot is not on hold (i.e., deviations, change controls etc.) prior to batch disposition. 

• Verify all previous manufacturing steps, including raw materials, are satisfactory prior to final disposition of the batch. 

• Complete all required system transactions associated with the batch disposition process. 

• Investigate deviations, as assigned. 

• Complete Environmental Monitoring Summary (ESUM) reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMS in the electronic ESUM database.

• Perform special projects as assigned by Batch Release Lead and QA Leadership Team. 

• Team member of assigned project team(s).  This includes, but is not limited to, review and approval of project related requirement documents, IS Change Requests, LabWare MDM forms, protocols, reports, user and functional specifications, etc. 

• Reviews QA Release processes, and recommends, develops and implements Quality Continuous improvements 

• Act as the author/review/approver of LRPs (Lot Release Protocols) for US and International submission.

• Provide data for PDR manufacturing dates and Commodity Verification Sheets to allow further processing of material

• Perform final Quality review of completed manufacturing records for completeness and accuracy according to site procedures, cGMP, FDA’s 21 CFR, and other applicable health authority regulations. 

• Ensure a constant state of inspection readiness and that audit observations are addressed on time and completed to maintain readiness levels

• Perform cGMP audits within functional areas by conducting a thorough review of processes and documentation. Identify and communicate cGMP compliance deficiencies to upper management, recommend appropriate corrective actions when necessary, and perform monitoring with respective functional area management to ensure compliance.

• Perform CAPA review and approval as required.

About You

Requirements:

• Minimum Bachelors degree, preferably in Science or Life Sciences,

• Minimum 2-3 years in a cGMP controlled/ pharmaceutical industry preferably

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testin