QA Release Associate
il y a 2 semaines
**Company Information**
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
**Role Overview**:
The QA Release Associate 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.
**Major Responsibilities**:
- 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.
**Qualifications**
**Education**:
A minimum of a Bachelor's Degree in Science, Information Science or equivalent technical discipline is required.
**Experience**:
**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.
- Good written and verbal communication skills are required.
- Ability to collaborate well with stakeholders, customers and peers.
- Flexible to work on weekends, as needed.
**Language Requirements**
Dutch and technical English
LI-AG1
Legend Biotech maintains a drug-free workplace.
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