Lab Director

Myriad Genetics•Salt Lake City, UT

1d•Onsite

About The Position

The Lab Director shares responsibility for the overall operations and administration of the laboratory, including the reporting of test results promptly, accurately and proficiently, and for assuring compliance with applicable regulations. They must also be accessible to the laboratory to provide on-site, telephone, or electronic consultation, as needed. The Lab Director is responsible for ensuring that consultation is available to the laboratory’s clients on matters relating to the quality of the test results and their interpretation concerning specific patient conditions. They are actively involved in the design, implementation, and oversight of the quality management system, including the monitoring of key indicators and investigation of problems with corrective/preventive action as appropriate. The Lab Director ensures that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which include pre-analytic, analytic, and post-analytic. They provide manager review of all new and/or substantially revised policies and procedures in a timely manner and in accordance with regulatory guidelines. The Lab Director ensures that policies and procedures are established for the lab director group that show individual members have the appropriate education, experience, training, and demonstrated ability to perform assigned tasks reliably and accurately. A system is in place to identify needs for remedial training or continuing education. Participation in Continuing Education to maintain necessary certifications and in Strategic Planning and Research and Development appropriate to the needs of the laboratory is also required. The Lab Director ensures that quality is the first consideration in all aspects of their job. They ensure that test methodologies selected have the capability of providing the quality of patient test results required for patient care, that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method, and that laboratory personnel are performing the test methods as described in the laboratory’s Standard Operating Procedures (SOPs) and as required for accurate and reliable test results. Participation in CLIA approved proficiency testing programs commensurate with the services offered is required, ensuring that proficiency testing samples are tested in the same manner as routine patient samples, results are returned within the specified time frame, all proficiency testing reports are received and reviewed by the appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action, and an approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory. Participation in the quality control and quality assurance programs to assure the quality of laboratory services provided and to identify failures in quality as they occur is also a responsibility. The Lab Director participates in the establishment and maintenance of acceptable levels of analytical performance for each test system and in remedial actions and documentation as needed, whenever significant deviations from the laboratory’s established performance characteristics are identified, and that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly. Ensuring that reports of test results include enough pertinent information for interpretation and ensure that test results are accurate based on scientific knowledge at the time the report is issued is also a key responsibility. The ability to occasionally work a variable schedule, including early mornings, evenings, weekends, and/or holidays is also noted.

Requirements

M.D., D.O., or PhD in a biological, chemical, medical technology, or clinical laboratory science.
Minimum of 4 years specialized training or pertinent lab experience in high-complexity testing.
Board certified by an HHS-approved board.
Holds/is working towards a NYS CoQ in the appropriate permit category if directly involved in NYS sample testing.
California only: Valid Clinical Laboratory Scientist (CLS) license or Clinical Genetics Molecular Biology Scientist (CGMBS) license issued by the State of California.

Responsibilities

Shares responsibility for the overall operations and administration of the laboratory.
Ensures the reporting of test results promptly, accurately and proficiently.
Assures compliance with applicable regulations.
Remains accessible to the laboratory to provide on-site, telephone, or electronic consultation, as needed.
Ensures that consultation is available to the laboratory’s clients on matters relating to the quality of the test results and their interpretation concerning specific patient conditions.
Actively participates in the design, implementation, and oversight of the quality management system, including the monitoring of key indicators and investigation of problems with corrective/preventive action as appropriate.
Ensures that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which include pre-analytic, analytic, and post-analytic.
Provides manager review of all new and/or substantially revised policies and procedures in a timely manner and in accordance with regulatory guidelines.
Ensures that policies and procedures are established for the lab director group that show individual members have the appropriate education, experience, training, and demonstrated ability to perform assigned tasks reliably and accurately, and that a system is in place to identify needs for remedial training or continuing education.
Participates in Continuing Education to maintain necessary certifications.
Participates in Strategic Planning and Research and Development appropriate to the needs of the laboratory.
Ensures that quality is the first consideration in all aspects of their job.
Ensures that test methodologies selected have the capability of providing the quality of patient test results required for patient care.
Ensures that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.
Ensures that laboratory personnel are performing the test methods as described in the laboratory’s Standard Operating Procedures (SOPs) and as required for accurate and reliable test results.
Participates in CLIA approved proficiency testing programs commensurate with the services offered.
Ensures that proficiency testing samples are tested in the same manner as routine patient samples.
Ensures that results are returned within the specified time frame.
Ensures that all proficiency testing reports are received and reviewed by the appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action.
Ensures that an approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.
Participates in the quality control and quality assurance programs to assure the quality of laboratory services provided and to identify failures in quality as they occur.
Participates in the establishment and maintenance of acceptable levels of analytical performance for each test system.
Participates in remedial actions and documentation as needed, whenever significant deviations from the laboratory’s established performance characteristics are identified, and that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
Ensures that reports of test results include enough pertinent information for interpretation and ensure that test results are accurate based on scientific knowledge at the time the report is issued.