Lead Clinical Laboratory Scientist Infectious Disease Testing

Overview

This job description describes a laboratory lead role responsible for performing high-complexity laboratory testing, quality control procedures, and maintenance of equipment and work area. The role serves as section lead, leads process improvement initiatives, and is responsible for employee training, task assignment, 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.
• 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.
• Lead on process improvement initiatives.
• 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.
• 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 the 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 relevant quality metrics, including 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.