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QA Senior Compliance Specialist – Operations
Company | Sanofi |
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Location | Framingham, MA, USA |
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Salary | $67500 – $97500 |
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Type | Full-Time |
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Degrees | Bachelor’s |
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Experience Level | Senior |
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Requirements
- Bachelor’s with 4+ years of experience, Associates with 6+ years of experience, or High School Diploma and 8 years of related experience in a Quality and/or CGMP environment.
Responsibilities
- Work closely with manufacturing, facilities, engineering, and Quality Control departments. Function as SME on challenges related to production requiring quality input.
- Review batch records, logbooks, equipment status documentation, cleaning records.
- Provide on-the-floor support, issue action notices, and cleaning logs.
- Represent QA during internal and external audits, addressing questions related to QA systems and product disposition.
- Approve non significant deviation investigations.
Preferred Qualifications
- Self-motivated
- Organized
- Excellent communicator
- Detail-oriented
- Strong interpersonal and project management skills
- Proficient in electronic document systems such as Trackwise and/or Veeva, Excel, Word, PowerPoint, and databases.