QA Release Weekend CAR-T

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Gent, East Flanders, Belgium

Job Description:

QA Associate, CAR-T (weekend)

 

Johnson & Johnson (J&J) is recruiting a QA 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 eliminate cancer cells expressing a specific antigen.

 

To support the CAR-T program in EMEA, J&J has build two CAR-T manufacturing centers in the Ghent area (Belgium).   The QC laboratories are operating from the existing J&J Beerse site.  CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities. 

 

In this role, you are reporting in the J&J QA CAR-T organization and work closely with your peers from Operations and Quality Control.

 

The QA Associate, CAR-T (weekend) is responsible to take part in, and oversee the release activities which take place during the weekend shift, i.e.

release of batches in line with all ATMP/GMP requirements whilst adhering to the established turn around timelines.

This position will involve working in a weekend shift (6AM - 6PM), on site.

Major Responsibilities:



* Batch Documentation Review/Release: Review and approve batch documentation to verify compliance with regulatory and company standards.


* Quality Assurance Oversight: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR T-cell products.

Provide guidance during the weekend in relation to the QA oversight on manufacturing and logistics processes.


* Investigation Support and CAPA Management: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations, complaints, and other quality issues to ensure timely resolution.


* Inspection and Audit Support: Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.


* Collaboration and Stakeholder Engagement: Foster and maintain effective working relationships with inte...