Quality Assurance Specialist – Cell Therapy
AstraZeneca · Medical Business, Netherlands
QualityFull-timeCompany career page
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Role summary
Quality Assurance Specialist role supporting cell therapy operations in Amsterdam. The position combines hands-on batch documentation review and quality record management with global quality management system activities, process improvement, and compliance oversight within a growing import hub facility.
What they're looking for
- Bachelor's or master's degree in life sciences or related field
- Minimum 2 years hands-on QA experience in GMP manufacturing environment
- Minimum 2 years writing and reviewing quality documentation including SOPs
- Minimum 2 years experience with deviations, CAPAs, and change controls
- Demonstrated knowledge of GMP and quality systems across US, EU, and global standards
- Experience with electronic QMS platforms; Veeva experience advantageous
- Professional English proficiency; Dutch language a plus
What you'll be doing
- Review batch documentation for disposition and QP certification; identify and coordinate resolution of missing or incomplete records
- Write, review, and update SOPs, procedures, and quality policies; manage change controls and review board meetings
- Investigate quality deviations and coordinate corrective and preventive actions across teams
- Compile and present quality systems data and metrics for management review meetings; prepare for audits and inspections
- Train colleagues on GMP, QMS procedures, and quality processes; identify and escalate compliance concerns
Privacy & handoff
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