Lab Director

Background:

Our large government client is looking to bring on their next CLIA Lab Director in Reynoldsburg, Ohio. This candidate will work directly with the Chief Administrator to plan, develop, and drive the vision and strategy of this laboratory. This candidate will have oversight of all activities in the lab and meet with staff, however, they will not be directly supervising any specific teams.

Job Responsibilities:

This position may work a hybrid schedule at the discretion of the manager or supervisor, which will require occasional attendance in the office for training, meetings and other operational needs

Employees must reside within a reasonable distance to their assigned headquarters for compliance with workplace reporting requirements

This Public Health Laboratory performs routine testing of patient and environmental samples for a multitude of tests

Newborn Screening

CLIA regulations require a high complexity laboratory to have a Laboratory Director available to oversee the overall operation and administration of the laboratory

As the CLIA Public Health Lab Administrator (Microbiology), you will plan, direct and manage the Bureau of Public Health Laboratory in all activities related to Microbiology testing to include proper testing, reporting results, test interpretation, development of test methodologies, setting of standards & certification of tests meeting CLIA/CAP certification requirements &/or other state & federal guidelines

Supervises supervisory personnel (e.g., microbiology supervisors)

Develops laboratory budget & monitors expenditures

Participates in developing new programs, methodologies & tests

Develops, implements & enforces laboratory policies, procedures & performance standards affecting wide range of entities (e.g., local health departments, agency institutions, hospitals, physicians)

Oversees all laboratory testing & research activities and provides scientific expertise to staff for all human related specimens (Microbiology and Radiation Chemistry, if applicable)

Provides continuous feedback and training; ensures that staff is qualified and cross-train microbiological staff to provide consistent and timely services

Provides assistance and guidance to the laboratory staff as an alternate Responsible Official for the Select Agent Program

Ensures regulations, policies, and procedures related to maintaining the Laboratory’s CLIA license are followed

Develops strategic planning initiatives

Provides guidance and oversight to the Bio Watch program/personnel (Bio Watch is a federal environmental air monitoring program) on matters pertaining to the operation of the program in the laboratory

Ensures timely review and approval of all laboratory procedure and safety manuals, review and approval of all proficiency testing results (before submission to vendor and upon receipt of evaluation report) demonstrated by comments, signature/date

Ensures an annual review of training and competency files and corrective action plans/reports demonstrated by comments, signature/date

Requirements:

This candidate must meet the Code of Federal Regulations 493.144

(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; OR

(2) Be a doctor of medicine, a doctor of osteopathy or doctor of podiatric medicine licensed to practice medicine, osteopathy or podiatry in the State in which the laboratory is located; and have at least one year of laboratory training during medical residency (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or have at least 2 years of experience directing or supervising high complexity testing; OR

(3) Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and o Be certified and continue to be certified by a board approved by HHS; or o Before February 24, 2003, must have served or be serving as a director of a laboratory performing high complexity testing and must have at least: (A) Two years of laboratory training or experience, or both; and (B) Two years of laboratory experience directing or supervising high complexity testing. OR

(4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; OR

(5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; OR

(6) For the subspecialty of oral pathology, be certified by the American Board of Oral Pathology, American Board of Pathology, the American Osteopathic Board of Pathology, or possess qualifications that are equivalent to those required for certification.