Lead Clinical Laboratory Scientist

Responsible for performing laboratory testing, quality control procedures and maintenance of equipment and work area; serves as section lead; serves as lead on process improvement initiatives; responsible for employee training and task assignment; assists with work scheduling and personnel management.

• Perform high-complexity laboratory testing using established methodologies, including molecular HLA typing, flow-cytometry, genetic analysis, HLA antibody screening (if applicable), ABO typing, and infectious disease testing
• Serve as section lead, providing oversight and guidance for designated laboratory areas
• Serve as the final reviewer to sign off clinical cases in all aspects of testing including technical, quality, billing, etc., as designated by laboratory management
• Document test results and all pertinent information; interpret different and complex reaction patterns; identify probable causes for any irregular or atypical test results
• Responsible for compiling and preparing section quality assurance reports
• Serve as lead on process improvement initiatives
• Accurately communicate results to internal and external customers including clinicians, transplant coordinators, and other OPO personnel
• Accurately enter, retrieve, and transmit test data into laboratory information systems
• Assist laboratory staff in testing procedures, quality controls and standard operating protocols.
• Provide instruction and guidance to new employees in testing procedures, quality controls and standard operating protocols
• Perform laboratory employee competency assessment, as required
• Provide laboratory employee support, direction and management, as requested by laboratory management
• Assist with personnel management as designated, including but not limited to, one-on-one meetings, performance evaluation, coaching, and disciplinary actions
• Assist with development, validation and implementation of new and / or revised procedures and protocols
• Preserve donor cells and serum samples for potential future testing, if needed
• Process blood samples received from patients waiting for a transplant
• Prepare reagents required to perform analysis and ensure reagents are available and usable
• Set up and monitor equipment required to perform tests
• Maintain established preventive maintenance schedules for assigned equipment
• Perform minor equipment repairs such as adjustments and calibration of equipment
• Maintain quality control records and logs; prepare, record and store data for future reference
• Monitor supply levels to ensure adequate levels are maintained
• Ensure cleanliness and organization of work area in accordance with safety standards
• Serve as on-call off-hours technical consultant for laboratory employees
• Work with laboratory leadership to develop, plan, implement, monitor and assess the laboratory quality assurance and performance improvement programs
• Identify non-conformances and deficiencies and manage the corrective action process
• Promote the culture of quality assurance and performance improvement throughout the laboratory
• Work with laboratory leadership to ensure compliance with all pertinent regulatory agencies, such as CMS / CLIA, FDA, UNOS, ASHI, and CAP
• Responsible for determining, tracking, trending and reporting of relevant quality metrics, including, but not limited to, turnaround times, error rates, customer satisfaction score, etc.
• Assist laboratory leadership with preparation for all internal and external audits and inspections; assist with follow-up as needed, including responses and corrective actions
• Complete continuing education

Education and Training Required

Experience and Skills Required