Clinical Labs Quality Specialist
Our client located in Rixensart is looking for support in Quality for their clinical laboratory.
The Responsibilities
- Ensure the follow up, quality support for the lifecycle of Clinical Laboratory assays and to manage the human biological samples logistics and testing for Laboratory activities.
- Ensure that business processes are well controlled (in place and in use) and, clinical assays are developed, qualified, or validated in compliance with applicable internal requirements.
- Review and approve deviations/CAPA and Change Controls linked to assays and HBS activities (including equipment.
- Review assay SOPs, method qualification and validation documentation as per processes and following good documentation practices.
- Identify quality risks and opportunities and escalate them as appropriate.
- Ensure regular Spotchecks in the labs to see if procedures are well applied by business and manage new identified risk or issue as relevant.
- Be the quality representative in multidisciplinary meetings.
- Make sure that Records, Standard Operating Procedures, and documentation has been completed and endorsed by the staff authorized to do so.
Skills and Knowledge Requirements
- University degree in Sciences (Bio Engineering, Biology, Chemistry…)
- Good technical and analytical Biological Testing knowledge is an asset.
- Knowledge in quality regulation and standard requirements covering GCLP/GCP/GLP/including ISO 9001 if possible.
- In depth knowledge and expertise of quality systems, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA.
- Management of laboratory Equipment is an asset.
- SAP and Veeva previous experience are an asset.
- Good communication skills
- Good knowledge of English (read, spoken, and written)
- Ability to manage time and priorities.
- Minimum 2 to 5 years of experiment
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
