QA Lab Associate Ipl Car-t
il y a 1 semaine
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 Ghent Belgium.CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system.
They are created from the patients' own T cells and are engineered to kill cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The IPL lab will perform the in process testing during the manufacturing process.The QA Lab Associate IPL CAR-T is responsible for providing quality oversight for the site IPL laboratory, in accordance with Janssen policies, standards, procedures, and Global cGMP's.
Key Responsibilities
- Provide compliance oversight for the IPL laboratories, ensuring accurate and timely review of laboratory investigations, performing analysis on quality indicating data and identifying any trends noted for QC data.
- Support drafting and approving of standard operating procedures.
- Perform spotchecks in the IPL Lab. to ensure compliance with written regulations, policies, procedures, and global procedures.
- Ensure nonconformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce nonconformances 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.
- Provide compliance oversight for analytical instrument qualification
Qualifications:
- Required:
- A minimum of a Master Degree in Engineering, Science or equivalent technical discipline
- A minimum of 2 years of experience in Quality Assurance
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- Excellent written and oral communication skills are required.
Preferred:
- Experience in biotechnology methods like flow cytometry, cell counting and viability is preferred
- Experience in cell culture is preferred
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