Quality Assurance (QA) Assistant - Cell and Gene Unit

pQuality Assurance (QA) Assistant - Cell and Gene Unit /pbrKlaar om te solliciteren? Voordat u dat doet, zorg ervoor dat u alle details met betrekking tot deze baan in de onderstaande omschrijving leest.brp3.228 - 4.346 /ppbAre you organiser, 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. /b /pAbout the Cell and Gene UnitpThe 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 . /ppThe 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. /pYour Key ResponsibilitiespAs a QA Assistant, you will provide day-to-day operational support to the CGU quality system. You will work to approved procedures and elevate exceptions and quality decisions to an authorised QA Specialist role. Responsibilities include: /pulliMaintaining controlled SOPs, work instructions, forms, templates and logbooks, including numbering, version control, issuance, reconciliation, periodic review, archiving and withdrawal. /liliFormatting and routing documents through review and approval workflows, maintaining controlled document registers, and ensuring current approved versions are available at the point of use. /liliPreparing material disposition packages for raw, starting and ancillary materials, consumables and other GMP materials; completing routine dispositions only where authorised. /liliChecking supplier status, certificates, receipt and temperature records, material identity and status, and expiry or retest dates, and escalating discrepancies. /liliMaintaining quarantine, released, rejected and expired status in relevant systems, and coordinating labels and segregation with warehouse and manufacturing. /liliPerforming initial completeness and Good Documentation Practice checks of production, QC and material records before formal QA review. /liliRegistering and administratively supporting deviations, CAPAs, changes, risk assessments, training records and quality trackers, including follow-up of actions and due dates. /liliSupporting audits, inspections and GMP/TE activities through document retrieval, evidence packs, archives and operational coordination with QA, manufacturing, QC and clinical QA. /li /ulYour ProfilepYou 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. /pAdditionally, you bring:ulliAn MBO-4 or HBO qualification in life sciences, pharmaceutical or laboratory technology, quality or administration, or a comparable level gained through experience. /liliPractical experience in document control, quality administration, materials or warehouse operations, or another GMP/GxP-regulated environment; ATMP experience is an advantage. /liliBasic knowledge of GMP, Good Documentation Practice and data integrity, with strong attention to detail and organisational skills. /liliExperience with eQMS, document management systems and Microsoft Office is an advantage. /liliGood English level is required; Dutch is an asset. /li /ulWorking at the Princess Máxima CenterpWe 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. xgiwjmb The Princess Máxima Center operates according to the collective labor agreement ‘CAO ziekenhuizen’. /pbr