Sanofi Group Senior Quality Auditor in Framingham, Massachusetts
Title/Job: Senior Quality Auditor
Job Responsibilities/Department Description :
In this role, you will be responsible for the GMP compliance aspects of the production of clinical trial material (manufacturing and testing). The type of manufacturing groups governed includes buffer/media preparation, cell culture operation, purification, and fill/finish operation.
Primary duties of this position include review and audit of batch records, and validation reports, inspection of manufacturing and testing laboratories, raw material. buffer/media release.
Other essential support duties of this position include tracking of deviations, CAPA's, metrology discrepancies, facility events, product and environmental investigation, Risk assessments and SOP development.
QC microbiology knowledge is a plus, as this position will be involved in site contamination control strategy.
The function also will be performing internal and external audit.
- Bachelor's degree (BS/BA) in a scientific discipline with 5-8 years industry experience in quality or manufacturing/testing including experience in cGMP, pharmaceutical quality system.
Strong technical background in regulated products.
Excellent communication skills both written and verbal.
Effective time management and organizational skills.
Strong attention to detail and ability to work with others in a group environment.
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.