Specialist ELISA - QC

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

As a Specialist ELISA - QC, you will play an important role within the team as the subject matter expert for ELISA. You will support QC analysts with questions related to ongoing ELISA methods and ensure that QC activities are carried out to a high standard in accordance with the applicable GMP and safety guidelines. The role is primarily focused on specialist support, investigations and improvement activities, with very limited hands‑on laboratory work.

We are constantly striving to better organise and further improve our processes. To this end, we enthusiastically use various Lean/Six Sigma tools such as tiers, kaizens and root cause analysis. We are looking for an experienced Specialist ELISA - QC who is open to change, continuous improvement, self‑critical and thinks in terms of solutions rather than problems.

Responsibilities

• Knowledge of serological ELISA potency testing and being a subject matter expert is a requirement.
• Supporting QC analysts with questions related to ongoing ELISA methods, including facilitating regular ELISA support sessions.
• GMP knowledge is a requirement.
• Identifying, analysing, coordinating and reporting (OOS) deviations and trends, including necessary cross‑functional laboratory investigations in accordance with applicable GMP procedures.
• Implementing and/or leading corrective and preventive actions and improvement initiatives arising from deviations, including CAPA and 8‑step root cause investigations.
• Supporting and leading change controls related to ELISA methods and processes.
• Point of contact for the QC department with regard to deviations, changes, audits, training and documentation, such as system documents, SOPs and work instructions.
• Assessing QC test results.

Qualifications

• You have at least a completed higher professional education degree in Life Sciences, Medical Sciences or a related field and at least 3-5 years of work experience in a similar position.
• You have extensive experience with the ELISA technique. Strong ELISA knowledge and experience is a strict requirement for this position.
• You have extensive experience with GMP (Good Manufacturing Practice) and/or other quality systems.
• You have extensive experience with data analysis and root cause investigation in the event of deviations.
• You have good verbal and written communication skills in English and Dutch. Dutch is mandatory.
• You have an affinity with problem‑solving techniques such as 8 steps and 5 x why.

Working at PSS

Working at PSS means working with highly motivated people with a can‑do mentality. Our people work in an international environment, within an enthusiastic team and for an organization where there is sufficient room to develop further. Working together is extremely important to us and having fun in what you do is part of that. Our monthly team lunches, team activities and the hand out of awards to our colleagues are an example of this.

We also offer:

• A responsible and challenging position within the team;
• Plenty of room for your own ideas and input;
• Specialist training and a range of opportunities for personal and professional development;
• Online preventive mental health platform;
• Flexible working hours;

Working at PSS offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for motivated employees:

• Plenty of opportunities for growth;
• Varied work where you are in regular contact with other companies and scientists within the Eurofins group;
• A broad customer portfolio ensuring a lot of diversity in your work.