Role Overview:
The QA Investigator 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 supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and compliant product supply.

Major Responsibilities:

• Collaborate with site personnel to provide guidance and determine resolution for manufacturing
  issues.
• Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs,
  change controls and complaints.
• Perform analysis on quality indicating data and identifying trends.
• Collaborates with functional departments to resolve issues.
• Manage cross-functional projects with many stakeholders.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP
  requirements.
• Require minimal direction to complete tasks, knows how to get resources and information from
  established internal contacts; consult with manager for decisions outside established processes.
• Provide guidance to other employees in the interpretation of quality issues and participate in the
  development of technical or scientific initiatives and activities.
• Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
• Drive continuous improvement.

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.
• Proficient in applying process excellence tools and methodologies.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a
  positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a
  requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and
  current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is
  preferred.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

Language Requirements:
Dutch and technical English