The Companion Diagnostic Laboratory Technician is responsible for specimen processing, testing and monitoring test performance within a Quality Systems Regulation (QSR) compliant laboratory. The technician must demonstrate competency, as defined in the department’s training program, prior to performing independent testing. This position will work with department management and quality team members to ensure that laboratory activities are defined, documented and completed to support inspection readiness and that compliance is maintained through procedures, training, documentation and continuous improvement projects. The technician must be qualified to participate in FDA studies and audits.
Each employee’s specific job responsibilities are uniquely defined by their individual training plan and assigned duties, but are generally defined as follows:
• Complying with the laboratory’s technical, administrative and safety policies and procedures.
• Participating in the laboratory’s quality assurance plan, adhering to quality control and preventive maintenance policies and appropriately documenting these activities.
• Comply with QSR, CLIA, CAP and applicable state regulations.
• Following the laboratory’s policies and procedures whenever test systems are not within acceptable limits and documenting the problem and any corrective action.
• Troubleshooting and identifying problems that may adversely affect test performance and/or reporting of test results by initiating corrective action and using the defined electronic system to make the required management notification.
• Performing proficiency testing in the same manner as routine samples.
• Actively participating in successful and timely completion of training and competency assessment as outlined in the laboratory and departmental training programs.
• Where competency has not been approved by supervision, will work under the direct supervision of an employee competent on the task.
• Participating in continuing education according to accepted laboratory standards.
• Participates in departmental and cross-functional teams to resolve problems or implement projects.
• Can serve as a trainer on technical processes within the group.
• Assist in achieving and maintaining laboratory certifications as appropriate
• Ph.D. in life science with at least 1 year of molecular diagnostic laboratory experience; or
• Master’s degree in clinical laboratory or life science with at least 3 years of clinical laboratory work experience; or
• Bachelor’s degree in clinical laboratory or life science with at least 5 years of clinical laboratory work experience.
• Experience with molecular genetics testing
• Experience with laboratory and analysis software
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