QA Lab Associate Ipl Car-t
il y a 6 jours
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, Johnson & Johnson Innovative Medicine 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 in process Lab of the CAR-T cellular therapy products in accordance with internal 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 spot-checks in the IPL 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 implemented.
- 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.
- Provide compliance oversight for Lab expansion projects including analytical instrument qualification
**Qualifications**:
**Education**:
- A minimum of a Master Degree in Engineering, Science or equivalent technical discipline is required.
Experience and Skills:
Required:
- A minimum of 2 years of experience in Quality Assurance
- Knowledge of cGMP regulations and FDA/EU guidance is required.
Preferred:
- Experience in biotechnology methods like flow cytometry, cell counting and viability is preferred
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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