Sanofi Group Quality Auditor Principal in Framingham, Massachusetts
The position is part of the Quality Assurance team (Framingham R&D SQO) responsible for oversight of the manufacture, testing and release of Biological Clinical Trial products out of the Framingham R&D location. The Quality Auditor Principle 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.
Bachelors in a science discipline with minimally 9 years experience in a GMP environment in manufacturing, testing or quality assurance.
Experience with reviewing and auditing test and batch records associated with pharmaceutical products.
Experience with reviewing validation records of equipment, instruments and computerized systems.
Working knowledge of quality systems including Deviations, CAPA's and Change Controls and Risk Assessments.
Experience with internal and external audits.
Ability to lead or be a key QA member of selected project initiatives.
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, OQ's for equipment, analytical instruments, and computerized systems) including protocol review and approval and final report and data auditing.
Performing QA support role on deviations, CAPA's and change controls.
Perform internal audits of local departments and external audits of third parties.
Management of selected quality systems.
Review and release of incoming raw materials and buffer/media records.
Review and approval of SOP's and test methods.
Ability to travel up to 10 % is necessary. .
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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