Batch Control Technician

Responsibilities

• Verify the completeness and compliance of batch files for high-risk in vitro diagnostic reagent batches (transfusion safety, transplant, virology, immunohematology)
• Process a daily volume of files according to a defined schedule, respecting strict regulatory release deadlines
• Produce batch release notifications within required timeframes
• Identify discrepancies or missing elements and request necessary supplements from manufacturers
• Ensure traceability of all actions performed, including recording, archiving, and filing
• Integrate evolving procedures and tools within a constantly changing regulatory environment

Requirements

• Minimum Bac+2 in biology, biotechnology, or biological analysis (BTS, DUT/BUT, or Professional License)
• At least 1 year of experience in a laboratory setting (quality control, medical biology, or R&D)
• Foundational knowledge in immunohematology and/or virology
• Ability to understand biological test results and compliance logic
• Strong sense of quality requirements
• Proficiency in written French and English

About the Company

GMED is a French notified body designated for the conformity assessment of medical devices under Regulations (EU) 2017/745 and (EU) 2017/746. We are a leading organization in the certification of quality management systems for medical device manufacturers.