GMP QA Assistant – Cell & Gene Therapies

Prinses Máxima Centrum; Utrecht; On-site; EUR 36,000 - 49,000; Full time

Benefits offered by this job

Holiday allowance 8.33%

End-of-year bonus 8.33%

Job summary

The Princess Máxima Center in Utrecht is seeking a Quality Assurance (QA) Assistant for the new Cell and Gene Unit (CGU). This full-time role supports the CGU quality system through document control, material disposition and routine quality administration within a GMP environment.

You will format and route documents, maintain controlled registers, prepare disposition packages, check supplier records, and support audits and QA activities.

Qualifications

• Must have a life sciences, pharmaceutical or quality administration background.
• Experience with GMP/GxP-regulated environments is preferred.
• Strong attention to detail and organisational skills.

Responsibilities

• Maintain controlled SOPs, work instructions, forms and logbooks with version control.
• Format and route documents through review workflows and keep registers up to date.
• Prepare material disposition packages for GMP materials; perform routine dispositions as authorised.
• Check supplier status, certificates, receipts and temperature records; escalate discrepancies.
• Maintain quarantine, released, rejected and expired statuses in systems and coordinate labeling with warehouse/production.
• Perform completeness and Good Documentation Practice checks of records before QA review.
• Support deviations, CAPAs, changes, risk assessments, training records and quality trackers.

Skills

Detail-oriented

Structured work

Clear communication

Education

MBO-4 or HBO in life sciences/pharma/quality/admin

Tools

eQMS

Microsoft Office

Job description

The Princess Máxima Center in Utrecht is seeking a Quality Assurance (QA) Assistant for the new Cell and Gene Unit (CGU). This full-time role supports the CGU quality system through document control, material disposition and routine quality administration within a GMP environment.

You will format and route documents, maintain controlled registers, prepare disposition packages, check supplier records, and support audits and QA activities.