QA Micro associate > Johnson and Johnson > Joboolo BE :
Company : Johnson and Johnson Location : Ghent Flanders From : Talent BE
We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The QA MicroAssociate, 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 MicroAssociate 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.Your offer Education/Experience:
A minimum of a Bachelor's Degree in Engineering, Science or equivalent technical discipline is required.
Experience within the biological and/or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.
Key Capabilities, Knowledge, And Skills:
• Aseptic processing in ISO 5 clean room and biosafety cabinets • Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices • Detailed knowledge of the shop floor manufacturing process.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
• Ability to summarize and present results, and experience with team-based collaborations is a must • You like to explore new paths, to make full use of your knowledge and experience, as well as to expand it, so that new problems also get solutions.
• You see possibilities and you look for them, even when they are not immediately clear.
• You like to work in a team towards a common goal.
• You consider diversity an asset.
• You can deal with procedures and guidelines that require strict application, as well as situations where not everything is clear yet.
Our offer • The opportunity to participate in a progressive treatment that gives hope to patients in need.
• Being able to help shape a new venture from the start.
• An innovative working environment.
• Training on the job for this specific treatment.
• Opportunities to continue to develop and grow in an extensive and strong organization.
• An open-ended contract and a competitive remuneration package. Johnson and Johnson GhentFlanders
