QA Associate Cryo

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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 ofapplicableQuality 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 establishmentand implementationof 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 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: two-shift regime.

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

The anticipated base pay range for this position is:

€52.000,00 - €82.685,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.