Role Overview:

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.

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:

A minimum of 4 years relevant work experience is required. 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. 

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.

Language Requirements

Dutch and technical English

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