QA release associate
Publication date:
11 October 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Ghent
QA Release Associate at Johnson & Johnson (Ghent, Belgium)
Are you ready to make a meaningful impact in the fight against cancer? Join our team at Johnson & Johnson to support the innovative CAR-T program in Europe!
About Us: At Johnson & Johnson, we are dedicated to harnessing the power of the human immune system to create groundbreaking therapies that aim to eliminate cancer cells. As part of our commitment to excellence in healthcare, we have established two state-of-the-art CAR-T manufacturing facilities in Ghent, Belgium.
The Role: We are currently seeking a QA Release Associate to join our Quality Assurance (QA) team. In this pivotal role, you will ensure that product and process-related investigations, complaints, and batch record reviews are executed accurately and in compliance with ATMP/GMP requirements.
Key Responsibilities:
- Review batch documentation and analytical results.
- Conduct in-depth investigations with a focus on technical, quality, and compliance expertise.
- Timely investigation and escalation of deviations/complaints that may impact patients or product supply.
- Define adequate CAPAs for quality-impacting investigations.
- Support the preparation and follow-up of inspections and audits.
- Participate in quality oversight programs and document GMP approvals.
- Foster effective working relationships with business partners and Legend Biotech.
- Manage and implement various quality system processes.
- Provide coaching and training to operational and QA departments.