Quality Control Specialist

About the job

To strengthen our team, we offer a challenging position for a Quality Control Specialist to support our mission to ensure the highest quality for life-changing HLA testing reagents.

As Quality Control Specialistat GenDx, you are key member of our Quality Control (QC) team, responsible for maintaining and continuously improving our ISO 13485 and IVDR-compliant QC processes. You evaluate and interpret test results, ensuring compliance with the specifications. Your work guarantees that our reagents meet the highest quality standards, providing the best products for transplant diagnostics. In addition, you contribute to cross-functional projects to implement and optimize QC procedures for our newest product developments. You are ready to support our mission: improving the quality of life and survival chances for transplant patients worldwide.

Responsibilities

• Planning and coordination of reagent QC’s together with the Quality Control Coordinator.

• Authorization of reagent QCs, quality reports, and certificates of analysis (COA).

• Maintain and update QC reports, training forms, protocols, specification documents and SOPs.

• Perform QC data trend analysis.

• Improve and optimize QC procedures.

• Implement and coordinate validation of QC procedures for new products.

• Participate in deviation investigations, root cause analysis, and CAPAs.

• Working according to ISO13485 and IVDR standards.

About you

To succeed in this role, the following requirements apply:

Requirements

• BSc or MSc in Life Sciences, Molecular Biology, or a related field.

• At least 2 years of experience in a QC or manufacturing laboratory within the IVD or biotech industry.

• At least 1 year experience with coordination of (quality control) technicians.

• Hands-on experience with molecular biology techniques and data analysis, especially PCR-based methods and NGS sequencing.

• Detail-oriented with excellent documentation and organizational skills.

• Excellent command of English (written and spoken).

• Team player with a proactive and solution-oriented mindset.

• Familiarity with NCR/CAPA, IVDR and ISO 13485 QMS processes.

• You currently live near Utrecht Science Park or are willing to relocate within a reasonable commuting distance of the office.

Experience with any of the following activities is a plus:

• Writing/reviewing Standard Operating Procedures (SOPs) and/or protocols.

• Performing/supporting data trend analysis.

• Supporting internal and/or external audits.

About GenDx

GenDx is a global leader in molecular diagnostic laboratory solutions for high resolution tissue typing of both donors and patients and monitoring transplant success. We combine our cutting-edge software solutions, reagents for DNA sequencing-based HLA typing and Chimerism monitoring strategies with our excellent customer support including a comprehensive education program. Our products are sold all over the world through direct sales and distributors. The GenDx office is based at Utrecht Science Park in The Netherlands. Since 2022, GenDx is part of the Eurobio Scientific Group, headquartered in Les Ulis, France.

With a highly educated and motivated team of about 115 colleagues, we contribute to the quality of life of transplant patients. Do you want to be part of an innovative company that offers ample time for development?

What's on offer

• A team of like-minded people who all strive to deliver the highest quality products possible.

• An international working environment.

• New office facilities accommodating the GenDx café to enjoy your daily healthy lunch.

• Competitive salary.

• Pension scheme.

• Compensation for commuting traffic.

• Full-time employment contract, based on a 40 hour work week.

• Option to work part-time (0.8FTE minimum).

• Employee Assistance Program (OpenUp).

• Laptop.

• 25 holidays and a week paid Christmas leave

• Sport pass for Sports Center Olympos.