Lab Quality Project Coordinator
Brussels – Contracting
Your responsibilities ?
- Actively participates in the implementation of the accreditation ISO 17025 in the laboratory. Participation in the project management and the follow -up with all external supplier. Example : implementation of the QMS (Quality management system) as required by ISO 17025.
- Implement and validate new assays in clinical chemistry, hematological, coagulation, and urinalysis on appropriate automate
- Develops and maintains quality processes and SOPs in the Safety laboratory.
- Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
- Participation in the implementation of the Laboratory Information Management System from a point of view scientific.
- Monitoring of quality indicators, treatment of Non-conformities and claims as well as Corrective and preventive actions.
- Perform all quality control checks monitoring trends (Participation in the Quality Management System of the Laboratory).
- Ensure the control of the Safety laboratory environment, safety specification, maintenance and calibration of laboratory material required to conduct clinical activities.
- Ensure Safety Laboratory readiness for audits. Support and respond to internal and external Quality audits.
- Assure compliance of processes for all activity in the Safety analytical laboratory Identify and implement new operational work process to improve Safety laboratory efficiency.
- Prioritize and coordinate all efforts within the department and collaborate between disciplines/divisions (Clinical Development, Clinical Research Operations, Clinical Pharmacokinetics, Pharmacogenetics, and other Clinical Research Units) to resolve issues and accomplish organizational goals.
- Perform other related duties incidental to the work described herein.
- Minimum of a Diploma bachelor degree in Medical Biology or equivalent.
- 3 years experiences in ISO 17025 and/or 15189
- Experience in Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure is required.
- Strong knowledge in ISO 17025 and/or 15189.
- Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
- Thorough knowledge of clinical pharmacology and regulatory requirements.
- Experience with managing projects.
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.