Spécialiste – Assurance Qualité – Quality Assurance – Sur le Terrain – On the Floor

Spécialiste – Assurance Qualité – Quality Assurance – Sur le Terrain – On the Floor

Requirements

• Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience.
• 3 – 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices.
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
• Fluency in French and English as working language.
• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Responsibilities

• Provide real-time, on-the-floor quality oversight of manufacturing operations, ensuring strict adherence to cGMPs, SOPs, and process specifications.
• Make real-time quality decisions and escalate operational risks that may impact production.
• Perform routine facility walkthroughs to monitor suite maintenance, contamination control, and troubleshooting activities.
• Review and approve deviation records and minor manufacturing deviations.
• Ensure timely coordination and approval of change control records impacting manufacturing operations.
• Issue and maintain logbooks and laboratory notebooks, ensuring full traceability and compliance.
• Manage document archiving, including submission control and retrieval processes.
• Conduct Material Release, Batch Record Review, and Product Disposition in alignment with compliance requirements.
• Monitor key quality system metrics to drive compliance and process improvement.
• Provide QA oversight of the Environmental Monitoring Program for cleanrooms and utilities.
• Enforce the site’s Contamination Control Strategy through proactive quality interventions.
• Oversee the Facility Sanitization Program to ensure adherence to regulatory expectations.
• Partner with Manufacturing and MS&T to support deviation investigations and root cause analyses.
• Drive a culture of compliance and continuous improvement, fostering strong cross-functional collaboration.
• Support internal and external audits, including regulatory inspections.
• Contribute to the training and development of the QA team, ensuring high competency in quality operations.
• Author, review, and approve SOPs, Work Instructions, and training materials to align with industry best practices.

Preferred Qualifications

No preferred qualifications provided.