What are the responsibilities and job description for the QA Principal Compliance Specialist, Operations (Night Time Operations) position at Sanofi?
QA Principal Compliance Specialist, Operations (Night Time Operations)
Location : Framingham, MA
Make sure to apply with all the requested information, as laid out in the job overview below.
About the Job :
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Join our Quality Assurance (QA) Operations team at Sanofi’s Framingham Biologics facilities! We ensure cGMP compliance during manufacturing to guarantee the safety, quality, and efficacy of our products.
As the QA Principal Compliance Specialist, you’ll provide quality support and direction to Manufacturing, Quality Control, and support functions. You will be responsible for quality oversight of manufacturing and laboratory operations, complete batch record and analytical data review, and non-significant deviation review to ensure compliance with cGMPs.
Main Responsibilities :
- Collaboration : Work closely with manufacturing, facilities, engineering, and Quality Control departments. Function as SME on challenges related to production requiring quality input. May train junior employees.
- Compliance : Review batch records, cleaning logs, environmental monitoring documentation, column packing records.
- GEMBA Support : Provide on-the-floor support, issue action notices, and participate in Material Review Board preparation.
- Audits : Represent QA during internal and external audits, addressing questions related to QA systems and product disposition.
- Deviation Management : Approve deviation investigations, CAPA and GEMBA problem solving.
- Decision Making : Responsible for high complexity decision making related to Quality or Compliance and ensuring that risks or deviation from decisions made by the Quality representative are escalated as needed to ensure Safety, Identity, Strength, Purity, Quality (SISPQ) of product.
About You : Qualifications :
Basic :
Preferred :
Special Working Conditions :
Why Choose Us?
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.
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