ABMGG Certified Associate Director

Location
94080, South San Francisco
Salary
Market Rate
Posted
Sep 05, 2018
Ref
882840
Required Education
Doctorate/PHD/MD
Position Type
Full time

Position Summary:

As the Associate Laboratory Director, and one of our Laboratory Directors, you have clinical oversight of Apex laboratory testing.  You ensure that testing is properly performed, and applicable regulatory standards are met. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient test results.

Primary Responsibilities:

  • Review, approve, and sign-out reports for a variety of clinical molecular/cytogenetic and/or oncologic results, including NIPT, carrier screening, PGD/PGS, products of conception and oncology testing on platforms including SNP array analysis, NGS, and other methodologies.
  • Oversee the review of genetic and CNV variant data: interpret NGS and microarray results in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
  • Provide clinical and technical support for genetic counselors and other laboratory personnel.
  • Set standards for laboratory testing and acceptable levels of analytic performance and ensure these are maintained.
  • Analyze lab data, contribute to or write publications for high-quality scientific journals.
  • May serve as Technical Supervisor. The Technical Supervisor is responsible for ensuring:
  • Appropriate test method selection;
  • Adequate method verification to determine the accuracy and precision of the test;
  • Enrollment of the laboratory in a CMS-approved proficiency testing (PT) program for the test performed;
  • PT samples are tested in accordance with the CLIA requirements;
  • PT results are returned within the time frames established by the PT program;
  • PT reports are reviewed by the appropriate staff;
  • Corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory;
  • Quality assessment and quality control programs are established and maintained;
  • Acceptable analytical test performance is established and maintained for each test system;
  • Remedial actions are taken and documented when significant deviations from the laboratory’s established performance characteristics are identified, and patient test results are reported only when the system is functioning properly;
  • Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens;
  • Policies and procedures are established for monitoring personnel competency in all phases (preanalytic, analytic, and postanalytic) of testing to assure the ongoing competency of all individuals who perform testing;
  • Remedial training or continuing education needs are identified, and training provided; and
  • An approved procedure manual is available to all personnel.
  • Manage a team.  Review and approve assigned work; mentor and develop personnel, including dedicated succession planning and contingency management.
  • This role works with PHI on a regular basis both in paper and electronic form and has a access to various technologies to access PHI (paper and electronic) in order to perform the job.
  • Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
  • Must maintain a current status on Apex training requirements.
  • Employee must pass post offer criminal background check.

Qualifications:

  • MD/DO and/or PhD in genetics or related field required.
  • Current California laboratory director license as a Clinical Genetic Molecular Biologist or Clinical Cytogeneticist required.
  • ABMGG board-certified in Clinical Cytogenetics and/or Molecular Genetics, ABP board-certified in Molecular Genetic Pathology or equivalent doctoral-level board preferred.
  • Current Certificate of Qualification in Genetic Testing from the NYS CLEP preferred.
  • 2 or more years of experience in a CLIA-certified clinical laboratory setting analyzing, interpreting and reporting clinical genetic/genomic data.
  • Knowledge of CAP, CLIA, California, and New York state regulations.
  • Management experience required.