Sanofi Group Quality Compliance Official, Shop Floor QA - Vaccines in Swiftwater, Pennsylvania
Key Responsibilities :
Provide direct shop floor quality support to ensure manufacturing activities are being performed compliantly. Increase quality culture in the manufacturing areas by functioning as a first responder for non-routine events on the shop floor.
Provide procedural guidance to resolve compliance issues in real-time to support deviations reduction.
Enhance technical knowledge in cGMP of operators and shop floor managers by providing positive and constructive feedback/coaching.
Perform sampling activities (EM and CCA/G) as well as surveillance/audits, Daily Release reviews/approvals, trainings.
Support regulatory agency inspections by ensuring shop floor is in inspection readiness state at all times.
Must be able to qualify on aseptic gowning and aseptic techniques.
This position is 1st Shift, Mon to Fri. Scheduling subject to change based on business needs.
Bachelor's Degree (Science-based or related) or Higher with minimum of 1 year experience in related field or minimum 3-5+ years experience, in lieu of degree, in regulated industry, in a cGMP controlled/pharmaceutical industry with a demonstrable working knowledge of documentation review, contamination control, disinfection practices, quality assurance, aseptic processing, cGMPs and regulatory requirements.
Preferred experience in decision making, auditing, and deviation investigations.
Percentage of time:
Sampling (EM and CCA/G) - 65%
Technical Advice/coaching - 10%
Auditing / Audit Support - 10%
Deviation Support - 10%
Continuous Improvements - 5%
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.