14 set - Torino
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What You’ll Do:
Non si lasci sfuggire questa possibilità: si candidi rapidamente se la sua esperienza e le sue competenze corrispondono a quanto descritto di seguito.
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- Laboratory Oversight & Administrative
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- Provide effective and efficient scientific direction and oversight for the Bilbao laboratory safety and specialty testing (hematology, chemistry, immunoassays, flow cytometry, molecular…)
- Ensure the development, implementation, and compliance of standardized processes for CTI central lab
- Ensure that technical staff are qualified, and licensed as required, to perform and supervise all testing and have met training and/or competency requirements
- Responsible for designing, validating, and maintaining the technical accuracy and medical reliability of the laboratory tests
- Monitor all work performed in the laboratory to ensure that clinically reliable data are generated and efficiently reported
- Provide advice to sponsors and clients regarding the significance of laboratory findings
- Subject Matter Expert for client interactions and business development activities
- Act as operations representative for regulatory interactions that include FDA/CLIA/CAP/EMA/ISO, IVDR, etc
- Oversee and maintain relevant laboratory documentation to ensure inspection readiness
- Lead the development and continuous improvement of laboratory quality system and ensure adherence to established processes and plans
- Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments and nonconforming event reports
- Participate in the selection of partner laboratories
- Report all concerns of test quality and/or safety to Clinical Director, Global Laboratory Services
- Laboratory Quality Management System (QMS)
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- Working with Quality Assurance to support and enforce all aspects of the laboratory’s QMS to ensure conformance to requirements described in the Quality Management System and Clinical Labor
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