description du poste

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 - near graduates are also eligible

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 is an asset
• 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