QA Auditor - Rotterdam

pLocation – Netherlands (Rotterdam)Can you tell the difference between a failed run that has genuinely failed and one that was accepted with a deviation or technical error? /pJob DescriptionpbQA Manager, Specialty Lab /bLocation – Netherlands (Rotterdam)Can you tell the difference between a failed run that has genuinely failed and one that was accepted with a deviation or technical error?brLaat deze kans niet voorbijgaan; solliciteer snel als uw ervaring en vaardigheden overeenkomen met wat in de volgende omschrijving staat.brAre you the kind of person who finds a puzzle in the data rather than a box to tick?brReady to build real, hands-on auditing experience in a fast-moving specialty lab?briAt Cerba Research, we are committed to finding the best talent to join our team. We have partnered with Vector Talent to manage the recruitment process for this role. If you\'re interested in applying, please direct all applications and questions to Vector Talent. /ibrThe Global Quality team at Cerba Research is looking for a bQA Manager, Specialty Lab /b, based in Rotterdam, to strengthen quality oversight at one of our highest-volume specialty lab sites. This is a 12-month fixed-term role with genuine hands-on impact, supporting the shift toward rigorous study-based auditing across validation, analytical data and reports. /pAbout Cerba ResearchpWith over 40 years of clinical research expertise, Cerba Research has built a unique offering of services, which includes clinical trial management, specialty lab biomarkers services and medical devices diagnostics offerings. /ppCerba Research supports clients from research and development all the way through clinical studies and commercialization of therapies. We combine the deep therapeutic understanding and agility of a specialist with the capacity, breadth and global reach of a central lab. /ppOur extensive experience in central specialty laboratory services is key to our success, allowing us to provide clients with early scientific insights that optimize protocol development. /ppWe provide key laboratory services to biopharma, government and not-for-profit organizations, supporting clinical trials. Our global accredited laboratory network and connected logistical infrastructure covers the US, Europe, Asia-Pacific, Australia and Africa. /pWhy Join Us?ulliReal, Hands-On Auditing – You won\'t be reviewing paperwork from a distance. You\'ll be in the data, checking whether the science holds up, and building genuine audit expertise along the way. /liliSupport Where You Need It – You\'ll work alongside a Senior QA Manager who mentors and coaches as part of the role, so you\'re building skills, not just filling a seat. /liliMeaningful Scope, Fast – Rotterdam is one of Cerba\'s highest-volume specialty lab sites. What you do here matters immediately. /liliA Genuine Step in Your QA Career – Whether you\'re moving from a lab-based role into auditing, or building on early QA experience, this is a real opportunity to develop into study-based, regulatory-focused quality work. /li /ulHow You Will Add ValuepAs QA Manager, Specialty Lab, you will contribute to: /pulliPerforming study-based audits on validation, analytical plans, raw data and reports, ensuring findings are accurate and effectively reported /liliSupporting regulatory compliance across ISO13485, ISO15189, ISO17025, ISO9001, GCLP, GCP, GLP, IVD/IVDR, CAP/CLIA and GAPIV standards /liliContributing to a culture of quality and continuous improvement, identifying bottlenecks and proposing enhancements /liliSupporting CAPA and deviation management, working with owners to ensure timely, effective resolution /li /ulYour ResponsibilitiespParticipate in, perform, and review audit findings and reports for study-based audits, based on intended use and endpoint /pulliPerform internal audits and support, follow up on, and host external audits and regulatory inspections, in collaboration with the Global QA Audit and Vendor Qualification Team /liliReview proposed CAPA responses and work with CAPA owners to ensure adequate resolution /liliDetect deviations, support root cause analysis, and follow up on timely resolution of deviations, CAPAs and effectiveness checks /liliMonitor document control processes, ensuring records are created, revised and maintained appropriately /liliProvide ongoing education to staff on quality-related topics /liliParticipate in QA-related projects, supporting timely completion of objectives /li /ulJob RequirementspbAbout You /b /pulliYou're detail-focused, genuinely curious about how things work, and comfortable asking why something looks the way it does rather than just confirming it\'s signed off. /liliBachelor\'s degree in a relevant scientific field (biology, chemistry, medical technology or related), and/or 5+ years\' experience in Quality Assurance and laboratory operations /liliStrong background in laboratory operations, with an understanding of lab processes and quality control measures /liliIdeally you will have or some experience across ISO17025, ISO15189, ISO13485, ISO9001, GAPIV, GCP, GCLP, GLP, IVD/IVDR and CAP/CLIA /liliExperience performing internal audits and supporting external audits or inspections /liliComfortable working independently while contributing to a wider team /li /ulpFluent in English; Dutch and/or French is an advantage /ppAt Cerba HealthCare, we believe that the diversity of people, backgrounds, and perspectives is an essential asset in fulfilling our mission: to improve the health of everyone, everywhere. /ppWe are committed to providing an inclusive work environment that guarantees equal opportunities for everyone, regardless of age, background, sexual orientation, disability, or any other personal characteristic. xgiwjmb All talented individuals are encouraged to apply. /pbr