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GENERAL SUMMARY OF POSITION: 

Under the general direction of Lab Management, the Team Lead is responsible for all of the day-to-day technical and administrative activities of the specified laboratory within the newborn screening program to include supervision of staff.  The Team Lead manages all technical processes related to the specified laboratorys testing of newborns, from specimen receipt through analysis with validated protocols and documentation of testing. The Team Lead works under the direction of and reports to a Scientist responsible for the specified laboratory in order to develop, implement and evaluate new methodologies to improve current screening, and add new capabilities.  The Team Lead works with the Scientist, the Program Director, and the Quality Assurance Manager for development of Quality Assurance Activities and Safety protocols.  The Team Lead is responsible for implementing quality assurance and safety activities inclusive of written protocols, selection of appropriate equipment and instrumentation, LIMS relationships, employee training, competency assessment, operations improvement, and proficiency testing.

MAJOR RESPONSIBILITIES:

• Oversees the scheduling and work activities of Lab Analysts in a manner that assures accurate and timely clinical testing and reporting.
• Performs (under the guidance of the scientist), supervises and documents laboratory activities for the technical development, validation, performance and troubleshooting of laboratory assays (both laboratory-developed tests as well as kit assays) used in the screening procedures.
• Performs (with or without assistance from the scientist), supervises and documents laboratory activities for the validation, troubleshooting the performance of and management of instrumentation used in the screening procedures.
• Performs (with or without assistance from the scientist), supervises and documents laboratory activities for the validation, troubleshooting and monitoring of the instrumentation relationships with the Laboratory Information Management System.
• Maintains laboratory documentation of quality assurance, quality control, and competency data in accordance with program policies and CLIA requirements.
• Maintains and implements written policies and standard operating procedures.
• Participates in the establishment of, and follows safety, privacy and compliance protocols relevant to the laboratory section.
• Ensures that laboratory analysts are compliant with established safety, privacy and compliance protocols relevant to the laboratory section.
• Instructs other laboratory analysts in test methodologies and techniques.
• Performs laboratory assays (clinical or research) with appropriate documentation, as an integral member of the sections laboratory analysts, following validated protocols.
• Manages lab supply inventory, and assists the Scientist in the preparation and validation of reagents, materials and kits used in the laboratory.
• Participates (under the guidance of the scientist) in the research and development of new methodologies.

REQUIRED QUALIFICATIONS:

• Bachelors degree in chemical, life or clinical sciences or equivalent.
• 5 years of relevant experience including clinical laboratory experience.
• Must satisfy CLIA requirements for high complexity testing
• Skilled in the knowledge, performance, and interpretation of lab tests and techniques
• Skilled in computer file management and general software usage
• Skilled in clear communications and maintenance of good working relationships with co-workers
• Experience with productivity software (Excel, Access, Word)
• Flexibility in work schedule as required by laboratory section (i.e., weekend or holiday rotations)

PREFERRED QUALIFICATIONS:

• Practical knowledge of human biochemical or endocrine pathways, or genetics.
• A thorough understanding of regulatory issues (e.g. CLIA, OSHA) as they apply to clinical laboratory testing.
• Expertise in high-throughput biochemical or molecular analytical techniques and robotics/liquid handling.
• Experience with data analyses, experimental design, biostatistics, bioinformatics.
• Supervisory experience.
• Communications and writing skills for oral presentations, SOPs, internal communications, scientific reports.