QA Principal Compliance Specialist – Operations
| Company | Sanofi |
|---|---|
| Location | Framingham, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, Associate’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Masters with 7+ years, Bachelor’s with 9+ years, Associate’s with 11+ years, or High School Diploma with 13+ years in Quality/cGMP
- Experience in Quality Engineering/Assurance/Control
- Knowledge of cGXP regulations and biologics or similar manufacturing processes
Responsibilities
- Work closely with manufacturing, facilities, engineering, and Quality Control departments
- Review batch records, cleaning logs, environmental monitoring documentation, column packing records
- Provide on-the-floor support, issue action notices, and participate in Material Review Board preparation
- Represent QA during internal and external audits, addressing questions related to QA systems and product disposition
- Approve deviation investigations, CAPA and GEMBA problem solving
- Responsible for high complexity decision making related to Quality or Compliance
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