QA Specialist

Our client, a leading biotechnology organization, is seeking a Quality Assurance Specialist to support manufacturing and QC operations. The role focuses on managing investigations and driving continuous improvement to ensure high-quality standards in the production of advanced therapies.

• Review and complete routine non-conformance and deviation investigations within manufacturing and QC environments.
• Conduct interviews with laboratory personnel to provide quality insights for Trackwise investigation reports.
• Collaborate with stakeholders to implement effective CAPAs and ensure the timely completion of corrective actions.
• Propose and execute process improvements through the change management system.
• Monitor and report metrics on non-conformance investigations and quality performance.
• Maintain strict adherence to safety policies, quality systems, and cGMP requirements.

• You bring experience in quality assurance, specifically focusing on deviations and non-conformances.
• You possess knowledge of QC laboratory environments and cGMP standards.
• You have experience with CAPA management and change control processes.
• You're proficient in quality management software such as Trackwise.
• You're proactive and solution-oriented with the ability to respond to urgent departmental needs.
• You are fluent in English.

Nice to Haves

• Knowledge of Dutch.