Manager, Shop Floor Quality QA-Swiftwater, PA - Vaccine
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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… surveillance monitoring, sampling, auditing, deviation support, auditing of manufacturing areas for performance, audit support, and adherence to the program as documented, and review of area release documentation for daily use and following non-routine events.
50 % of time On Floor Support
20% Technical Advice
10 % Auditing / Audit Support
10% Deviation Support
10 % Continuous Improvements
Context of the job/major challenges
This 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 technical advice, real-time coaching, and training to support traffic and gowning, aseptic technique, cleaning and disinfection, aseptic process simulation procedures, utility monitoring, and gowning scenario decision making. This includes attending manufacturing shift changes, L1 board reviews, and providing quality input as applicable or escalating as necessary.
This Quality position ensures Quality compliance oversight for on the floor task, but not limited to:
Area Creation & Release
Environmental Monitoring Release
Out of Service Creation & Release
Tank Hook Ups
Aseptic Simulations / Interventions
Sterilization Run Reviews
Log Book Reviews
This position does not have any oversight of technicians/managers specifically at Swiftwater, PA. This position is 3rd shift – Sun-Thurs. Scheduling may change based on business needs.
Bachelor’s Degree or higher in a science-based or related field with 2-4 years of experience OR 6-8 years of experience in lieu of degree
2-4 years’ experience, in a Quality related role, in a cGMP controlled/pharmaceutical industry with a demonstrable working knowledge of documentation review, deviation investigation, contamination control, quality assurance, aseptic processing, cGMPs and regulatory requirements.
Preferred experience in decision making related to product disposition.
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.
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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