QA Associate Cryo

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: About Innovative Medicine    Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.   Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.   Learn more at https://www.jnj.com/innovative-medicine     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.

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, 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. undefined 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