What are the responsibilities and job description for the Quality Assurance Specialist – GMP Compliance (contract) position at Sanofi?
About the Role
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Quality Assurance Associate II for a 12 month contract to support GMP compliance activities within a manufacturing environment. This individual will play a critical role in ensuring product quality and regulatory compliance across production operations.
Main Accountabilities
- Ensure activities are conducted in compliance with applicable regulatory requirements.
- Maintain compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
- Conduct regular audits of production processes to identify and address quality issues.
- Collaborate closely with production to ensure quality standards are upheld across the product lifecycle; presence on the shop floor is highly recommended.
- Manage and resolve quality-related issues effectively and promptly.
- Monitor and analyze quality performance metrics, and implement corrective actions as needed.
- Lead root cause investigations for quality incidents and develop preventive measures.
- Participate in internal and external audits and inspections, providing required support and documentation.
- Develop and implement risk management strategies to prevent potential quality issues.
- Promote a culture of quality and continuous improvement throughout the organization.
Key Responsibilities (D = Do, A = Advise, I = Inform)
- D: Request corrections when GMP rules are not respected.
- A: Prioritize quality and compliance objectives.
- D: Implement remediation actions from internal/external audit findings.
- D: Request quality improvement initiatives and strategies.
- D: Identify discrepancies and propose corrective/preventive actions.
- I: Escalate GMP execution failures to upper management.
- I: Inform stakeholders of quality performance, findings, and corrective measures.
- A: Advise on how to present topics and respond to specific questions.
- A: Advise on risk management strategies and planning.
- A: Recommend initiatives to support a quality-driven culture.
Required Technical Skills
- Strong analytical skills for complex data and trend analysis.
- High attention to detail and accuracy in QA activities.
- Effective written and verbal communication skills with internal teams and regulators.
- Strong problem-solving abilities and experience implementing corrective actions.
- Capable of managing multiple tasks while ensuring quality and compliance.
Qualifications
- Experience: 3 – 6 years in a Quality Assurance or GMP-regulated environment
- Education: Bachelor’s Degree or higher in a scientific or technical discipline
