QA Auditor - Rotterdam

Cerba Research; Rotterdam; On-site; EUR 75,000 - 100,000; Full time

Job summary

Cerba Research in Rotterdam is seeking a QA Manager for the Specialty Lab to strengthen quality oversight at a high-volume site. The role involves hands-on auditing across validation, analytical data and reports, with a 12-month fixed-term commitment and tangible impact on study-based quality measures.

You will collaborate with the Global QA team to ensure regulatory compliance and drive CAPA processes, while mentoring junior staff and supporting continuous improvement in laboratory operations

Qualifications

• Bachelor's degree in biology, chemistry, medical technology or related field.
• 5+ years' experience in Quality Assurance and laboratory operations.
• Experience working with ISO17025, ISO15189, ISO13485, ISO9001, GCP, GLP and CAP/CLIA.
• Ability to perform internal audits and support regulatory inspections.
• Comfortable working independently while contributing to a team.

Responsibilities

• Participate in, perform, and review audit findings and reports for study-based audits.
• Perform internal audits and support external audits/regulatory inspections with the QA team.
• Review CAPA responses and work with owners to ensure adequate resolution.
• Detect deviations, support root cause analysis, and follow up on resolutions.
• Monitor document control processes and ensure records are current and accurate.
• Provide ongoing education to staff on quality-related topics.
• Participate in QA projects, supporting timely completion of objectives.

Skills

Auditing experience

Attention to detail

Regulatory knowledge

Fluent in English

Education

Bachelor's degree in a relevant scientific field

Job description

QA Manager, Specialty Lab

Location – 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?

Are you the kind of person who finds a puzzle in the data rather than a box to tick?

Ready to build real, hands-on auditing experience in a fast-moving specialty lab?

The Global Quality team at Cerba Research is looking for a QA Manager, Specialty Lab, 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.

About Cerba Research

With 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.

Cerba 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.

Our 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.

We 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.

Why Join Us?

• Real, 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.


• Support 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.


• Meaningful Scope, Fast – Rotterdam is one of Cerba's highest-volume specialty lab sites. What you do here matters immediately.


• A 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.

How You Will Add Value

As QA Manager, Specialty Lab, you will contribute to:

• Performing study-based audits on validation, analytical plans, raw data and reports, ensuring findings are accurate and effectively reported


• Supporting regulatory compliance across ISO13485, ISO15189, ISO17025, ISO9001, GCLP, GCP, GLP, IVD/IVDR, CAP/CLIA and GAPIV standards


• Contributing to a culture of quality and continuous improvement, identifying bottlenecks and proposing enhancements


• Supporting CAPA and deviation management, working with owners to ensure timely, effective resolution

Your Responsibilities

• Participate in, perform, and review audit findings and reports for study-based audits, based on intended use and endpoint


• Perform 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


• Review proposed CAPA responses and work with CAPA owners to ensure adequate resolution


• Detect deviations, support root cause analysis, and follow up on timely resolution of deviations, CAPAs and effectiveness checks


• Monitor document control processes, ensuring records are created, revised and maintained appropriately


• Provide ongoing education to staff on quality-related topics


• Participate in QA-related projects, supporting timely completion of objectives

About You

• You'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.


• Bachelor's degree in a relevant scientific field (biology, chemistry, medical technology or related), and/or 5+ years' experience in Quality Assurance and laboratory operations


• Strong background in laboratory operations, with an understanding of lab processes and quality control measures


• Ideally you will have or some experience across ISO17025, ISO15189, ISO13485, ISO9001, GAPIV, GCP, GCLP, GLP, IVD/IVDR and CAP/CLIA


• Experience performing internal audits and supporting external audits or inspections


• Comfortable working independently while contributing to a wider team

Fluent in English; Dutch and/or French is an advantage

At 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.

We 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. All talented individuals are encouraged to apply.