Laboratory Director - Toxicology

Labcorp•Durham, NC

1d•Onsite

About The Position

The Laboratory Director is responsible for the overall operation and administration of the Clinical Laboratory, a high complexity testing laboratory, including: the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurate, and proficiently, and for assuring compliance with applicable regulations and accreditation requirements. The Laboratory Director has limited direct report influence, excellent leadership qualities are key to the success of this position. This position is a full-time, on-site position within our laboratory located in Durham, NC and serves as the Laboratory Director for CLIA, CAP LAP and NYSDOH.

Requirements

Doctoral degree (PhD, PharmD, etc.) in a chemical, physical, biological or clinical laboratory sciences from an accredited institution.
5 years or more of experience in Toxicology
6 years or more of experience in order to perform the duties of a supervisor under the requirements of NYSDOH.
Strong leadership skills, including collaboration, influencing others, decision making
Ability to problem solve and provide solutions under minimal supervision
Prior experience in a high volume, clinical laboratory environment
Strong working knowledge of CLIA, CAP and relevant state regulations
Previous experience working in an autonomous environment with a high degree of accountability
Strong presentation and communication skills; both written and verbal

Nice To Haves

Board certification by an HHS-approved board and maintain certification
Hold and maintain a Certificate of Qualification from the New York State Department of Health in the required categories

Responsibilities

Create/influence/support a collaborative laboratory environment that embraces compliance, efficiency, and change control.
Responsible for ensuring all duties are properly performed either by performing the duties of the technical supervisor, technical consultant, clinical consultant, and testing personnel, if qualified, or delegating these responsibilities to qualified personnel; maintains responsibility for any duties delegated to other qualified individuals
Provide on-site, telephonic and electronic consultation to laboratory personnel as needed
Ensure 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 includes the pre-analytic, analytic, and post analytic phases of testing
Ensure that the physical plant and environmental condition of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical, and biological hazards
Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care; Ensure that the verification or validation procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method; Ensure that the laboratory personnel are performing the test methods as required for accurate and reliable results
Ensure that the laboratory is enrolled in approved proficiency testing programs appropriate for all regulatory and accrediting agencies for the testing performed. The proficiency testing samples are tested as required by each regulatory agency. The results are returned with the time frames established by the proficiency-testing program. The appropriate staff to evaluate the laboratory’s performance and to identify any problems that require corrective action reviews all proficiency testing reports received. An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory.
Ensure that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur
Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system
Ensure that all necessary remedial actions are taken and documented and significant deviations from the laboratory’s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly
Ensure that reports of test results include pertinent information required for interpretation
Ensure that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions
Ensure that a general supervisor provides on-site supervision of high complexity test performance by testing personnel qualified under applicable regulatory and accreditation requirements
Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities as outlined by applicable regulations and accreditation requirements.
Ensure that prior to testing patient’s specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the service offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results
Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical, and post-analytical phases of testing to assure that they are competent and maintain the competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills
Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process
Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.
Ensures provision of educational programs, strategic planning, and research and development appropriate to the needs of the laboratory and institution.
Interacts with government and other agencies as appropriate, for laboratory-related matters
Provide support to various departments in the company including: Sales and Client Service areas; assist with sales calls and site visits by potential clients
Provide professional visibility for MedTox in attendance at professional meetings and lecturing at selected sites
Other duties may be assigned