The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab associate for the CAR-T hub in Europe. The position will be based in Beerse Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. The patients’ own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen.
To bring this life saving therapy to the patients, Janssen is looking for new talents to support the QA Lab organisation! So don't hesitate the patients are waiting!
The QA Lab Associate CAR-T is responsible for providing quality oversight for the release testing CAR-T cellular therapy products in accordance with Janssen policies, standards, procedures, and Global cGMP’s.
- Provide compliance oversight for the QC release laboratories (microbiology and biotechnology), ensuring accurate and timely review of laboratory investigations, performing analysis on quality indicating data and identifying any trends noted for QC data.
- Provide compliance and quality oversight for Lab instrument qualification
- Support drafting and approving of standard operating procedures.
- Perform spot-checks in the QC Lab. to ensure compliance with written regulations, policies, procedures, and global procedures.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
- Recognize patterns and trends in reported data and communicate to management.
- Provide guidance in the interpretation of quality issues and participates in the development of technical or scientific initiatives and activities.
- Routinely recognize and resolve quality issues. Seeks management guidance on complex issues. Develops procedures.
- Be able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Identifies risk and develops contingency plans.
- Drive continuous improvement.
- A minimum of a Master Degree in Engineering, Science or equivalent technical area is required.
- Experience in Quality Assurance in a GMP environment is a plus
- Experience in microbiological testing methods is preferred
- Experience in biotechnology methods like flow cytometry, qPCR, ELISA is preferred
- Experience in cell culture is preferred