ELISA QC Specialist: Lead Investigations & Process Improvement

Eurofins Scientific - Nederland; Boxmeer; On-site; EUR 55,000 - 75,000; Full time

Job summary

Eurofins Scientific - Nederland is seeking a Specialist ELISA - QC to act as the ELISA SME within the QC team. The role focuses on specialist support, investigations and improvement activities, with limited hands-on laboratory work, ensuring compliance with GMP and safety guidelines.

The successful candidate will mentor QC analysts, lead CAPA and 8-step root cause investigations, and drive change controls related to ELISA methods, while communicating clearly in English and Dutch.

Qualifications

• Completed higher professional education in Life Sciences or a related field.
• 3–5 years of work experience in a similar role.
• Extensive ELISA knowledge and hands-on ELISA experience.
• Strong GMP knowledge and familiarity with quality systems.
• Experience with data analysis and root cause investigations.
• Good verbal and written English and Dutch skills (Dutch mandatory).
• Affinity with problem-solving techniques such as 8D/5 Whys.

Responsibilities

• Serve as subject matter expert for serological ELISA potency testing.
• Support QC analysts with ongoing ELISA methods and run regular ELISA support sessions.
• GMP compliance and deviation analysis per GMP procedures.
• Identify, analyze, coordinate and report OOS deviations and trends with cross-functional teams.
• Lead corrective and preventive actions and CAPA investigations.
• Support and lead change controls for ELISA methods and processes.
• Be the point of contact for QC on deviations, changes, audits, training and documentation.
• Assess QC test results.

Skills

ELISA expertise

GMP experience

Data analysis

Root cause investigation

English proficiency

Dutch proficiency

Problem solving

Education

Higher education Life Sciences

Job description

Eurofins Scientific - Nederland is seeking a Specialist ELISA - QC to act as the ELISA SME within the QC team. The role focuses on specialist support, investigations and improvement activities, with limited hands-on laboratory work, ensuring compliance with GMP and safety guidelines.

The successful candidate will mentor QC analysts, lead CAPA and 8-step root cause investigations, and drive change controls related to ELISA methods, while communicating clearly in English and Dutch.