Lab Director

The Lab Director (in close co-ordination with the Sr VP Technical Development/Sr Lab Director, VP Clinical Genomics/Sr Lab Director, Sr Dir Lab Director, and Dir 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. Even if some of these responsibilities are reapportioned to other individuals, the Lab Director retains responsibility for ensuring that all duties are properly performed. They must also be accessible to the laboratory to provide on-site, telephone, or electronic consultation, as needed.

The Lab Director is responsible for:

1. 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.

2. Active involvement 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.

3. Ensuring 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.

4. Providing manager review of all new and/or substantially revised policies and procedures in a timely manner and in accordance with regulatory guidelines.

5. Ensuring that policies and procedures are established for the lab director group that show:

   1. Individual members of the lab director group have the appropriate education and experience;

   2. Individual members of the lab director group receive the appropriate training for the type and complexities of the services performed;

   3. Individual members of the lab director group have demonstrated they can perform assigned tasks reliably and accurately;

   4. Individual members of the lab director group are competent and maintain their competency to process specimens and;

   5. A system is in place to identify needs for remedial training or continuing education.

6. Participation in Continuing Education to maintain necessary certifications.

7. Participation in Strategic Planning and Research and Development appropriate to the needs of the laboratory.

8. Ensuring that quality is the first consideration in all aspects of their job.

9. Ensuring that:

   1. The test methodologies selected have the capability of providing the quality of patient test results required for patient care;

   2. Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method and;

   3. 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.

10. Participation in CLIA approved proficiency testing programs commensurate with the services offered and that;

    1. Proficiency testing samples are tested in the same manner as routine patient samples;

    2. The results are returned within the specified time frame;

    3. 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;

    4. An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.

11. 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.

12. Participation in the establishment and maintenance of acceptable levels of analytical performance for each test system.

13. Participation 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.

14. 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.

15. The ability to occasionally work a variable schedule, including early mornings, evenings, weekends, and/or holidays.

1. M.D., D.O., or PhD in a biological, chemical, medical technology, or clinical laboratory science.

2. Minimum of 4 years specialized training or pertinent lab experience in high-complexity testing.

3. Board certified by an HHS-approved board.

4. Holds/is working towards a NYS CoQ in the appropriate permit category if directly involved in NYS sample testing.

5. California only: Valid Clinical Laboratory Scientist (CLS) license or Clinical Genetics Molecular Biology Scientist (CGMBS) license issued by the State of California.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. In hiring and all other employment decisions, we prohibit discrimination and harassment on the basis of any protected characteristic, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.