Sanofi Group Manager Sterility Assurance, Swiftwater, PA in Swiftwater, Pennsylvania

The Manager Sterility Assurance (EDS):

  • Compiles and analyzes focus factory environmental monitoring data from LIMs and EM electronic data systems for trend reports, regular manufacturing meetings (EAC) and ad hoc requests.

  • Supports and maintains the integrity of EM databases by identifying and correcting errors, communicating errors to IO and driving corrections as part of the Data Management Systems Requests (DMSR) process., assigning sites and templates within the electronic systems and managing particle counters to assure EM Program, Area-specific SWIs and EM templates, sites and alarms are in alignment.

  • Completes environmental summaries to support batch release by compiling and reviewing data in compliance with area EM procedures and finalizing ESUMS in the electronic ESUM database, performing particle count review and approval per site procedures

  • Conducts system/process training, system audits (user and data accuracy)

  • Author and review Procedures, Instructions, Protocols, Reports, Data Packs and Training Modules

Requirements

Education/experience

  • Bachelor's Degree

  • 1-2 years’ experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, disinfection, microbiology, sterility assurance, aseptic processing, cGMPs and regulatory requirements

  • 1 year experience with Quality systems which may include SAP, Documentum, LIMS, and TrackWis

  • 1-2 years technical writing demonstrated by authoring reports, documents, forms, etc.

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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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life