Manufacturing and Supply
Where the
miracles of
science are made
a reality for patients

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 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:

Disposition of Batches

• 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 CBER release is received (if applicable) prior to batch disposition. 

• Verify the lot is not on hold (i.e., deviations, change controls, Approve for Further Manufacture database, 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. 

Quality Review of Lot Release Protocol (LRP)

• Review working LRP for completeness and accuracy prior to submission to the applicable Health Authority. 

• For licensed international products- ensure the batch is in full compliance with the GMP requirements and the specifications in the Marketing Authorization of the importing country. 

• Ensure LRP review meets cycle time requirements for product releases and SAP confirmation for completion of activity. 

Preparation of Environmental Monitoring Summary (ESUM)

• Oversee the ESUM process to ensure timelines and compliance standards are met. 

• Take assigned lots and complete ESUM reports by compiling and reviewing data in compliance with area EM procedures, finalizing ESUMS in the electronic ESUM database, and meeting release timelines. 

• Contribute to team objectives and priorities on assigned projects. 

Preparation & Certification of Working Documents

• Prepare batch records from master documents in the electronic document management system according to procedure 

• Ensure right first time preparation and completion of required documentation via electronic system (SAP and/or TrackWise) 

• Provide support as required to ensure records are prepared and certified in accordance to the production planning schedule. 

• Certified prepared batch records to ensure completeness and accuracy in accordance to procedure. 

• Provide metrics in support of +QDCI board meetings. 

Compliance and Performance

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

• Investigate deviations, as assigned. 

• Perform special projects as assigned by FFIP QA Leadership team. 

• Continuously reviews PQBR processes, and recommends, develops and implements efficiency and quality enhancements. 

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 testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com