Senior Specialist ELISA - QC

Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!

Role Overview

As a Senior Specialist ELISA - QC, you will play an important role within the team and ensure that QC tests are carried out to a high standard in accordance with the applicable GMP and safety guidelines, including trend analyses to identify opportunities for improvement. 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 Senior Specialist ELISA - QC who is open to change, continuous improvement, self-critical and thinks in terms of solutions rather than problems.

Key Responsibilities

• Serve as a subject matter expert in serological ELISA potency testing.
• Apply and maintain knowledge of GMP (Good Manufacturing Practice).
• Identify, analyse, coordinate, and report (OOS) deviations and trends, including necessary cross-functional laboratory investigations in accordance with applicable GMP procedures.
• Implement and/or lead corrective and preventive actions and improvement initiatives arising from deviations.
• Act as the point of contact for the QC department regarding deviations, changes, audits, training, and documentation, such as system documents, SOPs, and work instructions.
• Assess QC test results.

Qualifications

• Completed higher professional education degree in biology and at least 3-5 years of work experience in a similar position.
• Extensive experience with the ELISA technique.
• Extensive experience with GMP and/or other quality systems.
• Extensive experience with data analysis and root cause investigation in the event of deviations.
• Good verbal and written communication skills in English and Dutch. Dutch is mandatory.
• Affinity with problem-solving techniques such as 8 steps and 5 x why.

What We 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.
• Flexible working hours.
• Good salary and benefits.
• 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.

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.