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Part-Time/Remote Administative Lab Director - Toxicology
Ref No.: 17-00300
Category: Biotechnology
Location: Charlotte, North Carolina
This position will be responsible for upholding regulatory compliance and directing the laboratory to deliver patient reports using proprietary tests. Additionally, the role will oversee all related production lab operations including: monitoring performance metrics, auditing and inspecting readiness, staff training and evaluation, standards for experimental validations, optimization of workflow methods, and resource planning. This role will report to the VP of Lab Operations.

Responsibilities:
  • 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 their 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 the laboratory is enrolled in an approved proficiency testing program for the testing performed and that the proficiency testing samples are tested as required by CLIA; the results are returned within the timeframes established by the proficiency testing program.
  • Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care; verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method; and laboratory personnel are performing the test methods as required for accurate and reliable results.
  • Leading a laboratory team and building infrastructure for business growth.
  • Develop policies, procedures, and performance standards to ensure efficiency and quality.
  • Responsible for CAP, CLIA, NYS DOH and other licenses, as applicable.
  • Ensure QC, QA, and QI practices remain consistent with company policies and regulatory standards.
  • Work in conjunction with product development and R&D teams to oversee validation of new tests and help manage transition to the production laboratory.
  • Perform other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state or federal regulations
Basic Preferred Profile:
  • Applicant shall hold an MD or PhD and HHS-approved board certification in relevant specialties (see below for details on HHS-approved boards.
  • 10+ years experience directing CAP/CLIA-certified clinical laboratory for high throughput diagnostic testing.
  • 5+ years of management and leadership experience preferred.
  • GLP, GCP, GMP, or FDA Experience is strongly preferred.
  • Experience in ensuring compliance to regulatory standards (i.e. CLIA, CAP, JC, CMS, DOH, etc.) and preparing for surveys are essential
  • Demonstrated ability to effectively lead others, work collaboratively and interactively with diverse staff within a team.
  • Six (6) years Clinical/Administrative experience with minimum of 3 years of leadership, Management and/or Director Level experience in a Hospital.
The qualification for a laboratory director of high-complexity testing is that the laboratory director must hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS. The current approved boards are the following:
  • ABB – American Board of Bioanalysis
  • ABB public health microbiology certification
  • ABCC – American Board of Clinical Chemistry
  • ABCC 24-month Commission on Accreditation in Clinical Chemistry (COMACC)
  • ABFT – American Board of Forensic Toxicology
  • ABHI – American Board of Histocompatibility and Immunogenetics
  • ABMG – American Board of Medical Genetics
  • ABMLI – American Board of Medical Laboratory Immunology
  • ABMM – American Board of Medical Microbiology
  • NRCC – National Registry of Certified Chemists
MUST BE A US CITIZEN OR ELIGIBLE TO WORK IN THE US FOR ANY EMPLOYER. NO SPONSORSHIP WILL BE PROVIDED.