quality assurance associate (quality on the shop floor associate).

As a Quality Assurance Associate, you will report directly to the Quality Assurance Supervisor and will be responsible for ensuring compliance and monitoring the quality of shop floor activities throughout the manufacturing process.

The Quality on the Shop Floor Associate is responsible for Quality Assurance for routine GMP (Good Manufacturing Practices) shop floor activities in the Bulk Drug Substance and Aseptic Fill & Finish of biological products. They will work closely with the shop floor teams to ensure the production of a quality product while identifying areas for improvement and proactively reducing compliance risks.


Tasks & responsibilities:

• Review documentation related to the production process in the production area (e.g., batch records)
• Observe critical activities in the production area and assist in real-time problem-solving. The individual provides continuous support in the area and collaborates with production teams to implement actions to ensure product quality.
• Support compliance with GMP and internal procedures by defining and maintaining the partnership between Quality and Operations.
• Coach operational teams in event management.
• Collaborate with shop floor teams and provide support in problem-solving and root cause analysis of deviations.
• Conduct planned and unplanned shop floor visits to ensure process application or identify areas for improvement.
• Serve as the point of contact in the production area for all Quality-related matters.
• Proactively identify potential quality risks in collaboration with production.
• Report observations during governance meetings.
• Provide context for decisions.
• Share knowledge/coaches.

Requirements:

• Technical and scientific academic training
• 2 to 3 years of experience in a cGMP environment within a Quality Operations or Manufacturing department at a pharmaceutical site producing sterile injectable products
• Knowledge of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental monitoring, etc.
• A person with a strong affinity for working in a production environment
• Works collaboratively with partners, coaches, and provides context for quality requirements.
• Partner but does not replace Production
• Identifies, documents, and shares best practices, potential opportunities for improvement, and even discrepancies in a factual manner
• Has the ability to simplify complexity
• Has excellent listening skills
• Communicates easily
• Full professional proficiency in French

Sounds interesting? Apply now – we’re looking forward to receiving your applications!