Sanofi Group Compliance Specialist in Framingham, Massachusetts
Who You Are
You are a flexible learner who can take on multiple aspects of Quality Compliance. You have the ability to work across the organization to influence Quality Culture and ensure adherence to procedures and GMP processes. You excel in a fast-paced and dynamic environment requiring problem solving and attention to detail. You enjoy working in a collaborative and supportive team setting.
Who We Are
The Quality Assurance (QA) department is responsible for quality oversight of operations
at Sanofi Framingham Biologics facilities. QA main responsibility is to ensure adherence to
CGMPs during manufacturing operations through partnership with the site and direct
engagement with daily operations activities. QA is responsible for providing support and
guidance to the Sanofi Operations function in order to protect the safety, quality and
efficacy of Sanofi’s products, thereby ensuring the availability of compliant and safe
products for our patients and assuring the security of the company’s business and global
Where We Are
Our Framingham facility is located within a suburban community about 20 miles west of Boston in beautiful affordable Central Massachusetts with convenient highway access, free on-campus parking, and available shuttle service.
Our campus complex currently incorporates thirteen buildings as part of our R&D and Manufacturing Operations. Sanofi recently completed a multi-year capital expansion with several buildings constructed using “green” technology and resources including the 8 New York Avenue location which was recently heralded as the International Society Process Engineers (ISPE) Factory of the Year.
Provide Gemba Support
Perform batch record review
Perform review of column packing and qualification records
Function as SME on input related to quality decisions
Approve Non-conforming material discards
Perform log book review
Provide on the floor (OTF) support to the operations department, including OTF support for
critical operations steps
Issue action notices and conduct affiliated provisional release
Conduct log book audits against compliance requirements
Review Cleaning Verification (CV) related documentation against specification
Perform media / buffer and intermediate release
Prepare Bioreactor summary
Support internal audit preparation activities as well as cross-functional internal audit activities
and conduct walkthrough inspections
Execute containment activities
Provide off-hour support for batch record and log book issuance
Partner with manufacturing and support operations to ensure a culture of continuous
May provide training to new employees
Revise procedures / SOPs
Initiate and Investigate and QA review deviations
Perform Bulk Gas release
Review NRSR (Non Routine Sample Requests)
Bachelor’s Degree in a scientific field and 2 years of related experience, Associate's Degree and 4 years of related experience or High School Diploma and 6 years of related experience in a Quality and /or other CGMP related field.
Bachelor’s degree in a non-scientific field with 4 years of related experience in a Quality and / or cGMP environment.
Experience with quality systems and cGMP data review.
Basic to Intermediate computer proficiency, strong verbal and written communication skills.
Experience in bio-pharmaceutical industry.
Experience in Quality Systems
Effective time management, attention to detail, organizational skills, teamwork and collaborations.
Demonstrated competence in problem solving methodology.
Experience working in an environment of operational excellence.
Terms of Employment
• Ability to gown and gain entry to manufacturing areas
• Ability to work a 12-hour rotating shift and every other weekend, including some holidays
• Ability to lift 10 lbs.
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.