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

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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.
• Assist in the 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, including protocols, standard operating procedures (SOPs), batch records, and validation reports.
• Assists the QA Cryopreservation Manager for the establishment and implementation of Company-wide quality policies, strategies and practices.
• Audits & Inspections: Prepare for and participate in internal and external audits and inspections. Lead audit response activities and implement corrective actions as necessary.
• Setting up and maintaining key performance quality indicators.
• Deviation Handling

Experience and Skills:

• A bachelor degree is required.

Preferably in medicines, (medical biology), laboratory sciences, or a related discipline such as cell biology, but this is not considered a must.

• Proficiency in English and Dutch (verbal and written), as well as good personal communication skills are required

• Interest or knowledge in cell therapies and oncology is a plus
• Previous experience in a GMP or GTP environment, hospital or blood bank environment is preferred but not a must.
• Good documentation practices is a nice to have
• Soft Skills: Problem-solving mentality and ability to work effectively in cross-functional teams (teamplayer).

Must be open to a flexible work regime, for example: two-shift regime or Saturdays.

Training and qualification will be provided in a standard day shift regime.