Cryo Lab QA Associate – CAR-T & GMP Quality

jj; Beerse; Sur place; EUR 52 000 - 83 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson Innovative Medicine Supply Chain in Beerse, Belgium, seeks a QA Associate Cryo Lab to support CAR-T programs across EMEA. The role partners with the QA Cryopreservation Manager to ensure quality systems, release cryopreserved material, and manage deviations.

The position involves two-shift flexibility, cross-functional collaboration, and ongoing documentation reviews in a GMP/GTP environment. Training will be provided on day shifts initially.

Qualifications

• A bachelor degree is required.
• Proficiency in English and Dutch (verbal and written) is required.
• Interest or knowledge in cell therapies and oncology is a plus.
• Previous GMP or GTP experience in hospital or blood bank environments is preferred but not required.

Responsabilités

• Cooperate with the operational technology team and assist in Quality Assurance Oversight of daily operations of incoming fresh apheresis material for cryopreservation to support clinical and commercial requirements.
• Responsible for batch record review and release of the cryopreservation apheresis products; overview of Quality Agreements and Standards.
• Review and approve project documents including SOPs, batch records and validation reports; assist in establishing company-wide quality policies.
• Lead internal and external audits and inspections and drive corrective actions.
• Set up and maintain key performance quality indicators; manage deviation handling.

Connaissances

English

Dutch

Cross-functional teamwork

Formation

Bachelor's degree

Description du poste

Johnson & Johnson Innovative Medicine Supply Chain in Beerse, Belgium, seeks a QA Associate Cryo Lab to support CAR-T programs across EMEA. The role partners with the QA Cryopreservation Manager to ensure quality systems, release cryopreserved material, and manage deviations.

The position involves two-shift flexibility, cross-functional collaboration, and ongoing documentation reviews in a GMP/GTP environment. Training will be provided on day shifts initially.