quality coördinator lab

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Job description

• 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 to support our client needs. 
• 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 lab  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.
• Represent the client on global initiatives as a Laboratory subject matter expert, including regular interaction with the client for best practices and complementarity.
• Perform other related duties incidental to the work described herein.
• Complying with theStandards, ethical standards, ICH, regulatory and legal requirements, national and European laws on health and safety at work, fire prevention and other appropriate legislation.

Profile

• 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.
• Strong attention to detail. Highly productive, able to manage time and prioritize tasks to meet timelines.
• Candidate must possess strong problem solving abilities.
• Demonstrated ability to function as an effective and professional team member in diverse workgroups to accomplish business objectives.
• Good understanding of medical, clinical research, Lab Data Management process and terminology.
• Excellent communication, planning and organization skills required.
• IT Knowledge : Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
• Language skills : Good written and verbal skills in English, French and/or Dutch are essential
• Excellent organizational and time-management skills.
• Excellent communication skills), including public presentations and ability to communicate complex concepts clearly and concisely.
• Developing processes for continual improvement.