- Bureau à Ghent
The QA Release Specialist is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes paper/electronic batch record reviews related to the manufacturing of viral vector and autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. Job duties are performed within a team according to an assigned, production shift schedule.
What can you expect
- Reviews documentation for all manufacturing activity execution in accordance with good documentation practices.
- Independently executes paper/electronic batch record review associated with commercial, development, and engineering production.
- Performs duties under limited supervision and according to standard operating and manufacturing procedures.
- Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
- Implements appropriate corrective and preventive actions by investigating non-conformances in a timely manner.
- Strive to reduce non-conformances in supported areas by dedicatedly driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
Who are we looking for?
Education:
- A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required or two years of relevant work experience, preferably in an similar environment.
Experience:
- It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
Language:
- Dutch and technical English
Key Capabilities, Knowledge, and Skills:
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Great attention to detail and ability to follow the procedures.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
- Good written and verbal communication skills are required.
- Ability to collaborate well with stakeholders, customers and peers.
- The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
- Flexible to work on weekends, as needed.
What do we offer you?
- A meaningful job with an excellent work-life balance. You will work 4 days, followed by 4 days at home.
- A supportive and innovative work environment that encourages learning and personal development.
- The opportunity to work with people from all over the world.
- You start working through interim contracts. After 6 months you'll receive a permanent contract.
- An attractive salary package with numerous benefits, including additional statutory vacations, meal vouchers of €7/day , group and hospitalization insurance once you start your permanent contract, double vacation pay, and performance bonuses.
About Legend Biotech
Legend Biotech is a global biotechnology company dedicated to developing, manufacturing, and commercializing innovative and life-saving cell therapies for the treatment of chronic and life-threatening diseases, such as cancer.
The company was founded in 2014 and is headquartered in Somerset, New Jersey. Legend Biotech now employs over 2,400 people across six global manufacturing sites. Two of these sites are in Ghent: Obelisc (Technology Park Zwijnaarde) and Tech Lane (Eilandje Zwijnaarde).
In Ghent, Legend Biotech focuses on the production of advanced CAR-T cell therapies for the treatment of multiple myeloma, in close collaboration with Johnson & Johnson
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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
