MiraVista Diagnostics is actively seeking qualified candidates to fill the position of Laboratory Director. This is a full time role at the company’s onsite clinical lab in Indianapolis. The Laboratory Director must be qualified to manage and direct lab personnel and performance of high complexity diagnostic tests and must be eligible to be an operator of a laboratory within the requirements of CFR493.
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The Laboratory Director is responsible for setting the direction and coordination of all clinical lab services and personnel. This includes performance of testing in all departments of the clinical lab to obtain data for use in diagnosis and treatment of diseases. Additionally, the Laboratory Director ensures that services are of the best quality, meet regulatory requirements, are validated, are cost contained and are carried out in an expeditious manner. The Laboratory Director is also responsible for recognizing results or problems that require referral to MiraVista’s Medical Director.
- Provide leadership for the laboratory department.
- Evaluate the appropriateness of current laboratory methods for regulatory compliance, assay validation, clinical utility, cost-effectiveness and cost-benefit analysis.
- Identify opportunities for new test development or technology acquisition/transfer to menu of services.
- Assess, design, evaluate and implement new laboratory test methods and procedures.
- Provide technical assistance to laboratorians, physicians, veterinarians, manufacturers and consumers clinical laboratory testing services.
- Identify opportunities for collaboration with other laboratory directors, academicians, and vendors for clinical trials, contract testing of outside developed IVDs/LDTs, and implementation of new services/diagnostic devices at MiraVista Diagnostics.
- Present research findings at national and regional meetings.
- Serve as a clinical consultant as needed.
- Ensure testing systems provide quality laboratory services for pre-analytic, analytic and post-analytic phases of testing.
- Ensure verification procedures used are adequate to determine accuracy and precision of the method.
- Ensure that reports of test results include pertinent information required for interpretation and fulfill all regulatory statutes.
- Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.
- Maintain departmental records according to established policy and the requirements of all appropriate accreditation agencies.
- Oversee preparations for review by regulatory agencies, assist other department managers in maintaining appropriate policies and procedures to fulfill requirements and regulations.
- Is available for on-call duties.
- Performs other duties as assigned.
Oversight of Quality Control
- Establish a quality control program appropriate for the tests performed and establish the parameters for acceptable levels of analytic performance and ensure that these levels are maintained throughout the testing process.
- Ensure that quality control and quality assurance programs are established and maintained to identify fluctuations in quality as they occur.
- Ensure that remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly.
- Identify training needs of staff and ensure testing personnel receive regular in-service training.
- Evaluate the competency of all testing personnel on an ongoing basis.
- Evaluate and document performance of individuals responsible for testing.
- Establish and monitor criteria for the immediate notification of the practitioner responsible for the patient, when critical limits of specified test results are exceeded; implement corrective actions as required.
- Responsible for the Clinical Laboratory proficiency testing program commensurate with all tests and services performed.
- Ensure that PT samples are tested in the same manner as patient samples.
- Ensure that all laboratory testing personnel perform proficiency testing as equally as possible.
- Ensure that proficiency test results are returned on time to the PT program.
- Review all proficiency results, implement corrective action plan when results are unsatisfactory and ensure the corrective action plan is followed.
The Laboratory Director must be qualified to manage and direct laboratory personnel and performance of high complexity tests and must be eligible to be an operator of a laboratory within the requirements of CFR493.
- MD with ABP(CP), ABP(MMB), or ABMM Certification with at least 6 months of experience Or
- Ph.D. with ABMM Certification
- 5 years of experience managing clinical laboratory
- Demonstrated leadership ability