Jobs

Research Lab Quality Coordinator

Discipline
Engineering
Sector
Life Science
Location
Vlaams-Brabant
Vacancy ID
54402

Responsibilities

  • As a Research Lab Quality Coordinator, you support the implementation of an analytical laboratory for processing safety laboratory test.
  • You actively participate in the implementation of the accreditation ISO 17025 in the laboratory.
  • You participate in the project management and the follow-up with all external supplier.
  • You implement and validate new assays in clinical chemistry, hematological, coagulation and urinalysis.
  • You develop and maintain quality processes and SOPs in the safety laboratory.
  • You collaborate immediately with the laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
  • You participate in the implementation of the Laboratory Information Management System from a point of view scientific.
  • You monitor quality indicators, treatment of non-conformities and claims as well as corrective and preventive actions (CAPA).
  • You perform all quality control checks monitoring trends (Participation in the Quality Management System of the Laboratory).
  • You ensure the control of the safety laboratory environment, safety specification, maintenance and calibration of laboratory material required to conduct clinical activities.
  • You ensure safety laboratory readiness for audits. You support and respond to internal and external quality audits.
  • You assure compliance of processes for all activity in the safety analytical laboratory identify and implement new operational work process to improve safety laboratory efficiency.
  • You prioritize and coordinate all efforts and collaborate between disciplines/divisions to resolve issues and accomplish organizational goals.
  • You represent global initiatives as a laboratory subject matter expert, including regular interaction for best practices and complementarity.

Requirements

  • Master in a scientific field
  • At least three years in clinical research or experience in analytical techniques
  • Full knowledge of analytical validation procedure
  • Thorough knowledge of clinical pharmacology and regulatory requirements (GLP,GCP, ISO17025)
  • Good written and verbal skills in English, French and/or Dutch are essential
  • Demonstrate ability and flexibility in case of urgency to ensure safety coverage of volunteers/patients and clinical trials

Let us handle the details

We at STAR are happy to take care of the details

01 // Education and development

Standing still in this fast-changing market is not an option. That's why you can combine this position at STAR with courses to further your specialist knowledge and skills. It's the best of all worlds: work, learn and be part of a challenging project all at the same time. Whether you need a springboard to launch your career or simply want to update your expertise, the training programmes offered by our STAR Academy ensure that your qualifications are always in line with your ambitions.

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