QA Associate Cryo Lab

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium

Job Description:

Position Title: QA Associate Cryo Lab Beerse, CAR-T EMEA

At Johnson & Johnson,  we believe health is everything.

Our strength in healthcare innovation empowers us to build a  world where complex diseases are prevented, treated, and cured,  where treatments are smarter and less invasive, and  solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QA Associate Cryo Lab (M/F/X).

The position will be based in Beerse, 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, Janssen has constructed two CAR-T manufacturing centers in the Ghent area (Belgium), where CAR-T investigational medicinal and commercial CAR-T products are manufactured.

The newly build Cryo Lab will be operated from the existing Janssen Beerse site to provide the manufacturing facilities of their patients starting material. 

The QA Associate Cryo Lab works together with the QA Cryopreservation Manager and is accountable for the implementation of the overall EMEA CAR-T quality system in the Cryo Lab including compliance oversight, release of the cryopreserved apheresis material and deviation handling.

 

Major Responsibilities:


* Cooperate with the operational technology team and will assist in Quality Assurance  Oversight of the daily operations of all incoming fresh apheresis material for cryopreservation to support both clinical and commercial requirements in a new state of the art laboratory.


* Responsible for batch record review and release of the cryopreservation Apheresis products.


* Overview of applicable Quality Agreements and Standards.


* Document Control: Review and approve project-specific documents, inclu...