Quality Control Lead – Molecular Diagnostics

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 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.

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