QA Micro associate

CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.
We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we are developing a new production site.
We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The QA Micro Associate, CAR-T Europe is part of a team responsible for providing microbiological and aseptic oversight and contamination control of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. The QA Micro Associate will be based in Ghent, Belgium.

Major Responsibilities

• Work with Process Development team, Quality and Operations organization to ensure contamination control of facility to manufacture products, consistent with cGMP and Janssen requirements
• Performs aseptic qualification of manufacturing personnel (e.g. gowning, aseptic processing).
• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Drives the Aseptic Oversight program by execution of manufacturing floor surveillance.
• Actively support process microbiological investigations.
• Write relevant QC documents, SOP’s and WI’s.
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.