Quality Assurance (QA) Assistant - Cell and Gene Unit

Prinses Máxima Centrum voor kinderoncologie; Utrecht; On-site; EUR 42,000 - 48,000; Full time

Benefits offered by this job

Holiday allowance

End-of-year bonus

36-hour week

Job summary

The Princess Máxima Center for Pediatric Oncology in Utrecht is seeking a QA Assistant to support the Cell and Gene Unit (CGU) in a GMP environment. You will manage controlled documents, material disposition, and QA records to help ensure patient safety and compliance.

This full-time role (36 hours per week) offers a salary based on FWG 45, including 8.33% holiday allowance and 8.33% end-of-year bonus under the CAO ziekenhuizen.

Qualifications

• MBO-4 or HBO qualification in life sciences, pharmaceutical or laboratory technology, quality or administration, or comparable level gained through experience.
• Practical experience in document control, quality administration, materials or warehouse operations in GMP/GxP environments; ATMP experience is a plus.
• Basic knowledge of GMP, Good Documentation Practice and data integrity with strong attention to detail.
• Experience with EQMS, document management systems and Microsoft Office is an advantage.
• Good English level is required; Dutch is an asset.

Responsibilities

• Maintaining controlled SOPs, work instructions, forms, templates and logbooks with version control and archiving.
• Formatting and routing documents through review workflows and maintaining controlled registers.
• Preparing material disposition packages for GMP materials and verifying statuses and expiry dates.
• Checking supplier status, certificates and temperature records and escalating discrepancies.
• Maintaining quarantine, released, rejected and expired statuses and coordinating with warehouse and manufacturing.
• Performing completeness checks of production, QC and material records before QA review.
• Supporting deviations, CAPAs, changes, risk assessments, training records and quality trackers.

Skills

Attention to detail

English proficiency

Education

MBO-4 or HBO qualification in life sciences or related field

Tools

EQMS

Microsoft Office

Job description

Are you organised, accurate and motivated to support the safe manufacture of advanced cell and gene therapies? At the Princess Máxima Center, reliable documents, records and material status directly support patient safety. We are seeking a QA Assistant for the new Cell and Gene Unit (CGU). This operational role focuses on document control, material disposition, record checks and quality administration within a GMP environment.

About The Cell And Gene Unit

The Princess Máxima Center is building a state-of-the-art facility for manufacturing Advanced Therapy Medicinal Products (ATMPs). Alongside production, the CGU will support translational research to advance and refine innovative therapies. The unit will operate under GMP requirements and maintain a tissue establishment (TE) licence. Rachel shares more about working in the Cell and Gene Therapy Unit in this article.

The Princess Máxima Center

The Princess Máxima Center for Pediatric Oncology is an integrated hospital and research institute, which integrates healthcare, research and education on paediatric cancer, in a single location in Utrecht. Our institute aims to provide the highest level of care for all children with cancer, with optimal quality of life. The centre brings together the best possible care and scientific research, creating a unique interdisciplinary institute for paediatric oncology in Europe.

Responsibilities

As a QA Assistant, you will provide day-to-day operational support to the CGU quality system. You will work to approved procedures and ... Responsibilities include:

• Maintaining controlled SOPs, work instructions, forms, templates and logbooks, including numbering, version control, issuance, reconciliation, periodic review, archiving and withdrawal.
• Formatting and routing documents through review and approval workflows, maintaining controlled document registers, and ensuring current approved versions are available at the point of use.
• Preparing material disposition packages for raw, starting and ancillary materials, consumables and other GMP materials; completing routine dispositions only where authorised.
• Checking supplier status, certificates, receipt and temperature records, material identity and status, and expiry or retest dates, and escalating discrepancies.
• Maintaining quarantine, released, rejected and expired status in relevant systems, and coordinating labels and segregation with warehouse and manufacturing.
• Performing initial completeness and Good Documentation Practice checks of production, QC and material records before formal QA review.
• Registering and administratively supporting deviations, CAPAs, changes, risk assessments, training records and quality trackers, including follow-up of actions and due dates.
• Supporting audits, inspections and GMP/TE activities through document retrieval, evidence packs, archives and operational coordination with QA, manufacturing, QC and clinical QA.

Your Profile

You are precise, dependable and comfortable with structured, detail-oriented work. You follow procedures consistently, manage document and material workflows, and communicate clearly when information is incomplete or needs escalation. You enjoy supporting colleagues in a multidisciplinary team.

Additionally, You Bring

• An MBO-4 or HBO qualification in life sciences, pharmaceutical or laboratory technology, quality or administration, or a comparable level gained through experience.
• Practical experience in document control, quality administration, materials or warehouse operations, or another GMP/GxP-regulated environment; ATMP experience is an advantage.
• Basic knowledge of GMP, Good Documentation Practice and data integrity, with strong attention to detail and organisational skills.
• Experience with eQMS, document management systems and Microsoft Office is an advantage.
• Good English level is required; Dutch is an asset.

Working at the Princess Máxima Center

We offer a full-time position (based on 36 hours a week) in a very stimulating and interactive environment. The contract will be initially for one year, with the possibility to extend upon satisfaction. Your gross monthly salary (FWG 45) will be based on your experience and background and will include 8,33% holiday allowance and 8,33 % end-of-year bonus. The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’.