Quality Control Coordinator

Gendx Products Inc.

Utrecht

Hybrid

EUR 42,000 - 62,000

Full time

3 days ago
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Benefits offered by this job

Laptop
Commuting allowance
40h/week (1.0FTE)
Part-time option
25 holidays
Christmas leave
Employee Assistance Program (OpenUp)
Sport pass

Job summary

GenDx is seeking a QC Coordinator to join the Quality Control team at its Utrecht office. You will coordinate QC procedures for pre- and post-transplant products, ensuring molecular diagnostics kits meet the highest quality standards.

You will combine hands-on lab work with data analysis, planning, and cross-team collaboration, using techniques like (q)PCR, gel electrophoresis, Sanger sequencing, NGS, and long-read sequencing. ISO 13485 documentation is a key aspect of daily tasks.

Qualifications

  • Applied Sciences degree in molecular biology or equivalent.
  • At least 3 years of hands-on lab experience in molecular diagnostics, especially DNA sequencing, qPCR, and amplification technologies.
  • > 1 year of experience in a lab coordinator or equivalent role.
  • Strong planning, organizational, and collaboration skills; able to work independently and maintain attention to detail.
  • Team-oriented with proactive, hands-on mindset and knowledge of ISO 13485 requirements.

Responsibilities

  • Plan and approve QC activities, quality reports, and analysis certifications (COA).
  • Train and support QC technicians in the laboratory.
  • Perform QC procedures, analyze and interpret QC data.
  • Report and investigate deviations.
  • Document findings in a clear, traceable manner per ISO13485 requirements.
  • Maintain QC lab stocks, equipment, and a clean workspace.
  • Execute method validation and process improvements.
  • Work in compliance with quality standards and internal procedures.

Skills

Molecular biology
DNA sequencing
qPCR
Lab coordination
Planning
English proficiency
ISO 13485 knowledge

Education

Applied Sciences degree in molecular biology

Tools

PCR equipment

Job description

GenDx, where innovation drives diagnostics 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 transplant surveillance 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.

Being part of the GenDx team means joining a motivated team where everybody delivers their unique contribution to the quality of life and survival chances of transplant patients.

Do you want to be part of an innovative company that offers ample time for development?

To strengthen our team, we offer a challenging position for amotivated and detail-oriented QC Coordinator.

As Coordinator in the Quality Control (QC) team at GenDx, you will play a key role in coordinating QC procedures for our pre- and post-transplant products. You will be responsible for ensuring that our molecular diagnostics kits and reagents meet the highest quality standards before they reach our customers.

As part of the dynamic Operations team, and the QC team specifically, no two days are the same in this role, but you can expect a combination of hands-on lab work, data analysis, planning and cross-team collaboration. Your work involves a range of molecular biology techniques, including (q)PCR, gel electrophoresis, Sanger sequencing, next-generation sequencing (NGS) and long-read sequencing technologies.

Since we produce high-quality diagnostic products under ISO 13485 standards, precise documentation is an essential part of the role. In addition to planning and releasing QCs, your daily tasks will include analyzing results, performing laboratory tests, documenting findings, and collaborating with colleagues from Production and R&D.

In this role, accuracy, attention to detail, and a strong commitment to patient safety are essential. The work you perform directly supports clinicians and laboratories around the world in making reliable transplant decisions, ultimately impacting patient outcomes.

You will join a motivated and knowledgeable team working in a dynamic, innovative, and internationally oriented environment focused on excellence in molecular diagnostics.

Responsibilities
  • Planning and approval of QC’s, quality reports, and certification of analysis (COA).
  • Supporting and training of the QC technicians in the laboratory.
  • Perform QC laboratory procedures, analyze and interpret QC data
  • Report and investigate deviations
  • Document findings in a clear and traceable manner, in line with ISO13485 requirements
  • Maintain QC lab stocks, equipment and ensure a clean, organized work environment
  • Execute method validation and process improvements
  • Work in compliance with quality standards and internal procedures
Requirements
  • Applied Sciences degree in molecular biology or equivalent.
  • At least 3 years of hands-on lab experience as a technician, with excellent knowledge of molecular diagnostics, especially DNA sequencing, qPCR, amplification technologies.
  • > 1 year of experience in a lab coordinator role or equivalent.
  • Strong planning, organizational, and collaboration skills, with the ability to work independently and maintain attention to detail.
  • Team-oriented with a proactive and hands-on mindset
  • Strong affinity with quality and safety surveillance.
  • Experience with working in a (scientific) company, where work is done according to ISO 13485.
  • Excellent command of English (written and spoken).
  • You currently live near Utrecht Science Park or are willing to relocate within a reasonable commuting distance of the office.
  • To be considered for this position, you must be legally permitted to live and work in the Netherlands. Sponsorship for a work visa may not always be possible.
What do we 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 lunch together with your colleagues.
  • Laptop.
  • Compensation for commuting traffic.
  • Full-time position of 40 hours/week (1.0FTE).
  • Option to work part-time (0.8FTE minimum).
  • 25 holidays and a week of paid Christmas leave.
  • Employee Assistance Program (OpenUp).
  • Sport pass for Sports Center Olympos.
Information

For more information you can contact Walinka van Tol, Associate Director Quality Control, at +31 (0)30 252 37 99.

To be considered for this position, you must be legally permitted to live and work in the Netherlands.

We will take all steps reasonably necessary to ensure that your data is treated securely, and confidentially, in accordance with the GenDx Recruitment Privacy Policy .

GenDx does not consider unsolicited resumes from any third-party recruiters/agencies.

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