QA Compliance Official - Third Shift - Vaccine

CONTEXT OF THE JOB: 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. Quality oversight involves, but is not limited to deviation support, auditing of manufacturing areas for performance, regulatory audit support, documentation support, trending, risk assessments, adherence to the program as documented, and review of area release documentation following non-routine events. 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. OBJECTIVES: Provide direct shop floor quality support to ensure manufacturing activities are performed in compliance with effective SOPs & SWIs. Increase quality culture in the manufacturing areas. First responder to address any non-routine events on the shop floor. Provide guidance to resolve compliance issues and procedural errors in real-time. Perform periodic shop floor audits/walk-throughs. Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback. KEY RESPONSIBILITIES: Manage day-to-day shop floor QA needs Tagging area/equipment out of service Releasing area/equipment back in service Area/Line Clearances Oversee Product Pathway Assessment Review Documentation - Logbooks, SRNs, Daily Releases, Batch Records, etc. Deviations Support - Risk Assessments and Closures Aseptic behavior review and coaching Aseptic Process Simulations / Interventions Observations Audits, walk-throughs, GEMBAs, technical coaching DIMENSIONS/SCOPE: This is a 3rd shift position, Tue-Sat or Mon - Fri, and subject to move based on business justification. REQUIREMENTS: Bachelor''s Degree or Higher in a science-based or related field is preferred. A minimum of 1-3+ years'' experience, in a cGMP controlled/ pharmaceutical industry with demonstrable working knowledge of documentation review, deviation investigation, contamination control, disinfection, quality assurance, aseptic processing, cGMPs, and regulatory requirements. Preferred experience in decision-making, auditing, and deviation investigations. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. According to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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. GD-SP LI-SP 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. This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2025-11-01