Summary of Responsibilities
Are you a laboratory director who is focused on quality but looking for opportunity to help a company grow? We are looking for a Clinical Laboratory Director who is committed to maintaining our high-quality diagnostic testing services while demonstrating enthusiastic pursuit of new diagnostic testing opportunities. A well-networked individual in the medical laboratory field will be tasked with outreach to learn of unmet diagnostics needs and will actively pursue collaboration to incorporate new tests, conduct research studies, incorporate best practices and automation, and provide education to other medical professionals.
Essential Duties and Responsibilities
- Identify opportunities for collaboration with other laboratory directors, academicians, and vendors for clinical trials, contract testing of developed IVDs/LDTs, and implementation of new services at MiraVista Diagnostics.
- Identify opportunities for new test development or technology acquisition to menu of services.
- Assess, design, evaluate and implement new laboratory test methods and procedures.
- Identify, review, and implement automation related to the pre-analytical, analytical, and post-analytical processes
- Present research findings at national and regional meetings.
- Evaluate the appropriateness of current laboratory methods for regulatory compliance, assay validation, clinical utility, cost-effectiveness, and cost-benefit analysis.
- Provide technical assistance to laboratorians, physicians, veterinarians, manufacturers, and consumers of clinical laboratory testing services.
- 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 and up to 20% travel
- Performs other duties as assigned.
Oversight of quality assurance
- Responsible for oversight and continuous improvement of a quality assurance program appropriate for the tests performed and establish the parameters for acceptable levels of analytic performance.
- 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 (PT) 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 42 CFR 493.1357 and Part 58-1.2 of 10NYCRR.
Education and Experience
- Ph.D. with ABMM Certification or DMLI Certification
- 5 years of clinical laboratory experience as lab director
- Demonstrated leadership ability, networking, and incorporation of new tests into laboratory menu of services.
MiraVista Diagnostics is an Equal Opportunity Employer.
By signing this form I confirm my qualifications to perform the duties associated with this position. I also accept and acknowledge all responsibilities that have been defined and are required by this job description.