EMS Sampler

Our client is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. They are developing advanced cell therapies

The EMS SAMPLER is a 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.

• Serves as a Quality person in plant in support of cell therapy manufacturing.
• 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.
• Review and approve manufacturing procedures and batch records
• Real time review of all documentation and reporting in support of process unit operations and release activities.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Support regulatory inspections and audits by ensuring inspection readiness within facility.
• Perform internal housekeeping audits.

Do you have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy?

• Aseptic processing in ISO 5 clean room and biosafety cabinets.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• 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 summarize and present results, and experience with team-based collaborations is a must.
• Must be able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk.
• Must exhibit strong leadership skills and effectively develop others.
• Ability to collaborate well with stakeholders, customers and peers.
• Must exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
• Must be able to discern the criticality of issues and to communicate to management regarding complex issues.
• Ability to manage conflict and issues that arise with internal or external customers.
• Fluency in Dutch and English