What are the responsibilities and job description for the USA - Compliance Specialist II (Manufacturing/Quality) 1st Shift (contract) position at Sanofi?
Job Summary
Join Sanofi's contingent workforce program, FLEXT Direct, as a Compliance Specialist II for a 12-month contract. As a Compliance Specialist, you will play a crucial role in supporting Manufacturing by investigating, authoring, and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. You will be responsible for assigning corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address identified issues during production. Collaboration with cross-functional teams is essential to ensure efficient problem-solving and resolution of non-conformance issues, with regular communication of findings, actions, and improvements to relevant stakeholders and management.
Responsibilities
Join Sanofi's contingent workforce program, FLEXT Direct, as a Compliance Specialist II for a 12-month contract. As a Compliance Specialist, you will play a crucial role in supporting Manufacturing by investigating, authoring, and managing non-conformance reports (NCRs) for production and environmental monitoring (EM) events. You will be responsible for assigning corrective and preventative actions (CAPAs) and effectiveness checks (ECs) to address identified issues during production. Collaboration with cross-functional teams is essential to ensure efficient problem-solving and resolution of non-conformance issues, with regular communication of findings, actions, and improvements to relevant stakeholders and management.
Responsibilities
- Investigate both significant and non-significant NCRs for production and EM events.
- Analyze data to identify root causes for thorough investigation and issue identification.
- Write and maintain comprehensive NCR reports detailing causes, impacts, and actions taken.
- Strong analytical skills with the ability to identify root causes effectively.
- Excellent written communication skills for comprehensive report writing.
- Ability to work collaboratively in cross-functional teams for efficient issue resolution.
- Bachelor's degree in a related field or equivalent work experience required.
- Previous experience in compliance or quality assurance preferred.