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QUALITY ASSURANCE SPECIALIST FOR SINGLE-CELL AND SPATIAL OMICS

QUALITY ASSURANCE SPECIALIST FOR SINGLE-CELL AND SPATIAL OMICS

KU LeuvenLeuven, BE
30+ dagen geleden
Functieomschrijving

You have :

  • A master’s degree in biomedical sciences, engineering, or equivalent
  • Substantial QA experience in a biomedical, biotechnological, pharmaceutical or related discipline, or industry, is a prerequisite
  • Solid knowledge and understanding of various ISO certifications, including ISO-17025
  • Proficiency in GxP Regulations
  • Proven multi-project management skills and cross-functional project competence
  • Excellent communication and collaboration skills to work seamlessly across multicultural and interdisciplinary teams
  • Ability to communicate technical ideas in user-friendly language
  • Excellent verbal and written English communication and interpersonal skills
  • Experience with ethical / legal / biobank / GDPR compliance procedures is a plus
  • Experience with single-cell and / or spatial (multi-)omics research is a plus

As a QA Specialist, you will be responsible for implementing and maintaining a robust quality management system (QMS) and establishing ISO 17025 standards for our LISCO innovation and service laboratories. You will develop a comprehensive quality manual, provide training to personnel, ensure compliance with national regulations, standards, and other relevant requirements, and communicate deviations or new / revised requirements to the team. Through your dedicated efforts, you will significantly contribute to the establishment of LISCO’s innovation and service laboratories on KU Leuven’s biomedical campus.Challenges entrusted to you :

  • Monitor project implementation, progression and timely completion
  • Oversee quality and failure rates, initiating troubleshooting when necessary
  • Establish a QMS incorporating document control, record-keeping, corrective action, and internal audits
  • Develop a quality manual outlining the laboratories’ QMS, including policies, procedures, and work instructions
  • Conduct a gap analysis to identify disparities between current practices and ISO 17025 requirements
  • Train relevant laboratory personnel on the ISO 17025 requirements and the QMS, defining their roles and responsibilities
  • Develop well-documented procedures for testing processes (including sampling, handling, storage, analysis, and reporting of results), ensuring accuracy, precision, and reliability of results
  • Correct non-conformances identified during internal audits or external assessments
  • After ISO 17025 accreditation, participate in proficiency testing programs and maintain accreditation
  • Collaborate with research and service teams of diverse LISCO teams
  • Collaborate with other business and finance team members of LISCO

    • We are currently seeking a dynamic and passionate Quality Assurance Specialist (QA Specialist) to join a multi-disciplinary team headed by Prof. Thierry Voet at the KU Leuven Institute for Single Cell Omics (LISCO). In this role, you will spearhead quality assurance operations, ensuring strict adherence to quality control laboratory systems and processes on LISCO’s single-cell and spatial omics platform for biomedical research. As a vital member of our Operational Management Unit, you will play an important role in implementing a robust quality management system and establishing an ISO-certified environment.The landscape of biology and medicine is undergoing a transformation through single-cell and spatially resolved omics technologies. LISCO stands at the forefront of this revolution, actively reshaping our understanding of biology and medicine. An exciting opportunity to contribute significantly to the establishment of LISCO’s interdisciplinary technology and innovation platform on KU Leuven's biomedical campus. We offer a full-time (80% or 90% also possible) position for an indefinite period. If you can take up all responsibilities from the start, you will be appointed in grade 8. Promising candidates who are not yet able to take on all assignments immediately or still need to go through a specific training programme will start in grade 7. Grade 9 is exceptionally reserved for candidates who, due to their extensive knowledge and experience, can take on extra responsibilities right from the start. For other candidates this can be seen as a career path. Moreover, KU Leuven offers many extra legal benefits such as hospitalization insurance, group insurance, additional days of leave, free commuting by public transport, bicycle allowance, eco vouchers,...