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Randstad Logo Randstad · Quality Control

Quality Assurance Tester

Belgium, Beerse · Job Posted May 29, 2026
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Job Description

As a QA Micro Associate, CAR-T Europe, you will play a pivotal role in ensuring the microbiological and aseptic oversight of the production of autologous CAR-T products for clinical trials and commercial operations, which takes place in a controlled cGMP cleanroom environment, fostering contamination control and adhering to industry-specific regulations.

Job Responsibility

  • Collaborate with the Process Development team, Quality, and Operations organization to uphold contamination control of the manufacturing facility in alignment with cGMP and Janssen requirements
  • Conduct aseptic qualifications of manufacturing personnel, including gowning and aseptic processing
  • Define and impart specific aseptic techniques for crucial process steps through instructor-led trainings and awareness sessions
  • Drive the Aseptic Oversight program through manufacturing floor surveillance
  • Support process microbiological investigations actively
  • Develop relevant quality control documents, Standard Operating Procedures (SOPs), and Work Instructions (WIs)
  • Maintain, re-evaluate, and communicate key critical inputs for the site's environmental monitoring program
  • Identify risks and opportunities related to contamination control, collaborating closely with operators, Quality Control (QC), and operations management on improvement initiatives
  • Perform tasks in compliance with safety policies, quality systems, and cGMP requirements

Requirements

  • Bachelor's Degree in Engineering, Science, or an equivalent technical field
  • Experience in the biological and/or pharmaceutical industry, with relevant micro experience related to manufacturing
  • Aseptic processing in an ISO 5 cleanroom and biosafety cabinets
  • Knowledge of cGMP regulations, FDA/EU guidance, and Good Tissue Practices related to cell-based product manufacturing
  • Detailed knowledge of shop floor manufacturing processes
  • Strong organizational skills with the ability to work effectively in a team environment and a positive attitude
  • Excellent written and verbal communication skills in English
  • Record-keeping abilities in the form of notebooks, technical reports, and protocols
  • Ability to summarize and present results, and experience with team-based collaborations
  • Proactive, solution-oriented mindset with the ability to explore new paths and identify possibilities
  • Accept diversity as an asset
  • Ability to follow procedures and guidelines, even in ambiguous situations
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