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Job Information

Sanofi Group Compliance Official Manager, Shop Floor Quality QA-Swiftwater, PA in Swiftwater, Pennsylvania

Summary of purpose/major responsibilities

This Quality position ensures Quality compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the-floor presence.

This Quality position oversight involves, but is not limited to… auditing, deviation support, auditing of manufacturing areas for performance, audit support, documentation support, trending, risk assessments, adherence to the program as documented, and review of area release documentation and following non-routine events.

Key accountabilities

35% of time On Floor Support

15% Technical Advice

10% Leadership / Strategy

10% Auditing / Audit Support

10% Deviation Support

10% Continuous Improvements

5% Inspection Support

5% Trending / Metric

Context of the job/major challenges

This Quality position ensures Quality compliance oversight with cGMP, Regulatory, and Internal requirements regarding the manufacturing, testing, and distribution of products through real-time, on-the-floor presence.

This Quality position ensures Quality compliance oversight for auditing, deviation support, technical advice, real-time coaching, support traffic and gowning, aseptic technique, cleaning and disinfection, aseptic process simulation procedures, gowning scenario decision making, documentation support, trending analysis, risk assessment, adherence to site programs, area releases, and other non-routine events. This includes attending manufacturing shift changes, L2 board reviews, inspection support, risk assessments, and providing quality input as applicable or escalating as necessary.

This Quality position ensures Quality compliance oversight for specific on the floor tasks, but not limited to:

  • Area Creation & Release

  • Environmental Monitoring Release

  • Out of Service Creation & Release

  • Tank Hook Ups

  • Line Clearances

  • Water Leaks

  • Aseptic Simulations / Interventions

Dimensions/Scope

This position has oversight of technicians/managers specifically at Swiftwater, PA.

This position is 2nd/3rd shift Monday through Friday, and subject to move based on business justification.

Requirements

Education/experience

Bachelor’s Degree or Higher in a science-based field.

A minimum 3-5+ years’ experience, in a Quality Role, in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of documentation review, deviation investigation, contamination control, disinfection, quality assurance, aseptic processing, cGMPs and regulatory requirements.

Preferred experience in decision making, leadership, auditing, and deviation investigations.

Certifications

N/A

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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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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