What are the responsibilities and job description for the Compliance Specialist II (Manufacturing/Quality) 1st Shift (contract) position at Sanofi?
**Job Summary**
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Compliance Specialist II for a 12-month contract. The Compliance Specialist II will be responsible for performing complex tasks independently to ensure compliance with cGMP's in support of Label and Packaging operations, finished goods, and raw material disposition.
**Responsibilities**
Perform finished product disposition following Sanofi SOP's, in-house product specifications, and market regulations- Review and approve validation protocols and change controls
- Author, revise, and review SOP's through Veeva System
- Utilize Veeva for investigating deviations, CAPAs, and Change Controls
- Support compliance walkthroughs and participate in internal audits
- Interpret documentation for procedures and FDA enforcement actions/trends
- Analyze issues and provide recommendations for compliance improvements
- Complete Quality Events in Veeva
- Train new staff as needed
- Participate in specialized projects within Quality and cross-functionally
**Skills**
Strong understanding of cGMP regulations- Proficiency in utilizing Veeva System for documentation management
- Excellent analytical skills with the ability to identify compliance issues
- Effective communication skills for training staff and interacting cross-functionally
**Qualifications**
Bachelor's degree in a related field or equivalent work experience
This is an exciting opportunity to join a dynamic team at Sanofi's FLEXT Direct program. As a Compliance Specialist II, you will play a crucial role in ensuring quality compliance within Label and Packaging operations. If you are looking to utilize your expertise in cGMP regulations and make a significant impact on compliance processes, this position is perfect for you. Join us in our mission to deliver high-quality products while maintaining regulatory standards.
