Sanofi Group Senior Compliance Specialist in Framingham, Massachusetts
The Senior Compliance Specialis t uses knowledge of Compliance and GxP to manage investigation and improvement initiatives within Engineering. This position is responsible for performing a variety of tasks under minimal guidance and in accordance with current GMP’s.
Assisting Engineering Manager with:
Deviation Intake and Closure
GEMBA meetings with cross-functional team
Major/Critical Deviations - Technical Writing
Lot Tagging Adherence
Change Control Steps Completion
Implement Effectiveness Reviews
Practices safe work habits and adheres to Sanofi’s safety procedures and guidelines
Participates in cross-functional teams to drive investigation close-outs, determine root cause and implement appropriate corrective and preventative actions
Participates on cross functional Continuous Improvement teams with Manufacturing, Validation, Quality, Facilities, Metrology and Maintenance
Coordinates SME assessments for all CCR’s assigned to the Facilities and Engineering team
Works under general supervision and direction
Continuous improvement mindset
Performs routine documentation assessments to ensure alignment between SOP’s/Standards
Participates in cross functional projects and performs SME assessments for all CCRs assigned to Engineering
Effectively demonstrates understanding of GMPs and how it applies to specific responsibilities
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and/or cGMP environment
Associate Degree with 8 years of related experience in a Quality and/or cGMP environment
High School Diploma with 12 years of related experience in a Quality and/or cGMP environment
Advanced computer proficiency
Strong verbal and written communication skills
Experience with quality systems
Experience with cGMP data review
Adherence to on-time closures for quality metrics
Advanced technical writing proficiency
Special Working Conditions:
- Ability to gown and gain entry to manufacturing areas
Experience in cGXP manufacturing environment
Experience in troubleshooting, investigating, and root cause analysis in a GXP environment
Demonstrated skills in the following areas:
Problem solving and critical thinking
Advanced technical report writing
Verbal and written communication
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.
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.
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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