QA Lab Associate Car-t Ipl

Il y a 6 mois

Gent, Belgique Johnson & Johnson Temps plein

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 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 analytical instrument qualification

**Qualifications**:
**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.
- 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

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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