For one of our client, we are looking for an enthusiastic and experienced Laboratory Quality Coordinator.
Do you have a University Degree in Medical Biology or equivalent?
Do you have a previous experience as a Laboratory Coordinator?
Do you have a strong knowledge of ISO 17025 and/or 15189?
If this applies to you, don't hesitate to contact us and/or send your CV!
As a Laboratory Quality Coordinator, you will support the implementation of an analytical laboratory In-house for processing safety Laboratory test and will be responsible for the implementation of the ISO 17025.
- You actively participate to the implementation of the accreditation ISO 17025 in the laboratory of the company. You participate to the project management and to the follow-up with all external supplier (for example, implementation of the QMS as required by ISO 17025).
- You implement and validate new assays in clinical chemistry, hematological, coagulation, and urine analysis on appropriate automate to support the clinical Research Unit needs.
- You develop and maintain quality processes and SOPs in the Safety laboratory.
- You work in direct collaboration 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 scientific point of view.
- You are responsible for the monitoring of quality indicators, treatment of Non-conformities and claims.
- You manage corrective and preventive actions.
- 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. You identify and implement new operational work process to improve Safety laboratory efficiency.
- You prioritize and coordinate all efforts within the Clinical Research Unit 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.
- You represent the Clinical Research Unit on global initiatives as a Laboratory subject matter expert, including regular interaction with the New Haven Clinical Research Unit for best practices and complementarity.
- You perform other related duties incidental to the work described here in.
- You complying with the company's Standards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.
- You have a University Degree in Medical Biology or equivalent.
- You have at least 3 years experiences in ISO 17025 and/or 15189
- You have experience in Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure.
- You have a significant track record of experience and accomplishment in clinical and/or research laboratory setting.
- You have a good knowledge of clinical pharmacology and regulatory requirements.
- You have experience in project management.
- You pay a strong attention to detail. You are highly productive, able to manage time and prioritize tasks to meet timelines.
- You have strong problem solving abilities.
- You have a good understanding of medical, clinical research, Lab Data Management process and terminology.
- You have excellent communication, planning and organization skills.
- You have a previous experience in working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
- You are fluent in English and French or Dutch.