QA Manager, Specialty Lab: Study-Based Audits

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

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