POSITION OVERVIEW The position is part of the Quality Assurance team (Framingham R&D QSO) responsible for oversight of the manufacture, testing, and release of Biological Clinical Trial products out of the Framingham R&D location. The Quality Auditor position reports to the Quality Assurance Director of the department. Must have the ability to be able to work independently and as a team member. EDUCATION/EXPERIENCE REQUIREMENTS Bachelors in a science discipline with minimally 1 - 3 years experience in a GMP environment in manufacturing, testing, or quality assurance. Experience with executing or reviewing test or batch records associated with pharmaceutical / regulated products. Exposure to quality systems including Deviations, CAPA's and Change Controls and Risk Assessments. Ability to be a key QA member of selected project initiatives. THE MAIN DUTIES/RESPONSIBILITIES OF THE POSITION INCLUDE: Auditing of test records generated for release and stability timepoints of Phase 1 - 3 clinical products. Auditing of batch records including buffer/media, cell culture, purification, and fill-finish. Support of validation activities (IQ, OQs for equipment, analytical instruments, and computerized systems) including protocol review and approval and final report and data auditing. Performance of SQO Project Representative Role for selected programs as necessary. Performing QA support role on deviations, CAPA's, and change controls as necessary. Perform internal audits of local departments and external audits of third parties. Management of selected quality systems. Review and release incoming raw materials and buffer/media records. Review and approve of SOP's and test methods. Ability to travel up to 10 % is necessary. 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. Fully vaccinated, 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-SG #LI-GZ 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.