• Develop a nationally recognized CLIA reference laboratory.
• Ensure compliance with State and Federal regulatory agencies, including timely
submission of proficiency testing.
• Monitor patient testing and specimen acceptability to ensure accurate analytic
• Provide orientation and training to all testing personnel.
• Management of accessioning, test performance and critical analysis of patient results
reporting in collaboration with the laboratory director.
• Coordinate send-out testing to reference laboratories.
• Achieve greatest level of test accuracy, timeliness and medical value for a growing
• Work with R&D to validate clinical diagnostic instrumentation.
• Manage successful introduction of new tests to laboratory, and maintain existing
procedures, following NCCLS guidelines for SOPs.
• Oversee customer satisfaction and implement procedures for resolving complaints.
• Ensure competency of all testing personnel and high levels of team productivity and
• Work with Technical Supervisor and Lab Director to develop laboratory budget to ensure
efficient use of resources.
• Understand and implement OSHA and CLIA requirements.
• Bachelor's degree in chemical, physical or biological science or medical technology from
an accredited institution.
• Graduation from accredited CLS program
• Hold a current Clinical Laboratory Scientist license issued by the State of California
• At least two years of experience in high complexity testing, with proven track record of
exceeding quality expectations.
• Experience working with a broad array of assays including Clinical Chemistry,
• Desire to be part of a fast-paced, rapidly growing start-up company.
• Hematology, Microbiology, and Molecular Diagnostics.
• Experience managing clinical laboratory personnel.
• Experience managing new laboratories, or sections of laboratories, consistent with best
practices and lean/six-sigma principles is highly desirable.
• Strong knowledge and experience with public health laboratory laws and regulations.
• Proven ability to help scale clinical laboratories in a dynamic environment while
maintaining excellence in performance at every level.