QA Associate Cryo Lab Car-t
il y a 22 heures
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Associate for the CAR-T Cryo Lab in Europe. The position will be based in Beerse.
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 is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories and a new build Cryo Lab will be operated from the existing Janssen Beerse site.
The QA Associate Cryo Lab, CAR-T Europe works together with the QA Lead Cryo Lab 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**:
- She or he will cooperate with the operational technology team and will assist for start-up and subsequent QA 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 internal laboratory that is currently being built.
- She or he will assist in the batch record review and release of the cryopreservation Apheresis products.
- The QA associate Cryo Lab will also oversee training of people.
- Provides QA oversight of applicable Quality Agreements and Standards.
- Assists the QA Lead Cryo Lab for the establishment and implementation of Company-wide quality policies, strategies and practices.
- Assists the QA Lead Cryo Lab and Site QA Head for regulatory health authority inspections.
- Assists the QA Lead Cryo Lab in setting up and maintaining key performance quality indicators.
**Qualifications**:
**Experience and Skills**:
- A bachelor degree, preferably in medicines, medical biology, laboratory sciences, or a related discipline such as cell biology is required
- Interest or knowledge in cell therapies and oncology is required
- Knowledge of the EU tissue and cell directives and the JACIE standards is preferential
- Previous experience in a GDP, GMP or GTP, hospital or blood bank environment is preferred
- Proficiency in English and Dutch (verbal and written), as well as good personal communication skills are required
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