Lab Director

Lab Director

Irvine, CA, United States

$ 130,000.00 - 145,000.00 (US Dollar)

Laboratory Director

About Us

We are a licensed and accredited full-service medical reference laboratory with an extensive test menu of specialty assays. Our vision is to deliver information to our clinicians with accuracy, precision and speed so we have the most profound impact on the communities we serve. We are proud to deliver results you can trust, with some of the fastest turnaround times in the industry.

Job Overview

The Laboratory Director is responsible for the implementation and continued improvement of the Quality Management System through delegated authorities to members of this Laboratory Management Team.

Qualifications and Responsibilities:

• Qualifications and responsibilities assigned for required positions are appropriate for the complexity of testing as specified in the regulations.
• Quality Control (QC).
• Mechanism to ensure that the test process meets specific requirements for accuracy and precision and is working properly.
• Patient Test Management (PTM).
• Record keeping system to ensure positive identification and integrity of a patients specimen from the time of collection or receipt of the specimen through completion of testing, reporting of results, and billing.
• Proficiency Testing (PT).
• External test for accuracy offered by a private nonprofit organization or a Federal or State agency, or entity acting as a designated agent for the State required at least twice per year.
• Where external proficiency tests are not available, the laboratory shall perform an Alternative assessment at least twice a year.
• Quality Assurance/Quality Assessment (QA).
• An ongoing plan to monitor and ensure quality results; communicate and solve problems.
• COLA Accreditation.
• Meeting the Laboratory Accreditation Program Standards for Accreditation in the area(s) served by the laboratory.
• Accreditation is valid for two years and may be maintained on a continuous basis provided the following terms are met:
• Promptly notify COLA if:
• The laboratory becomes the subject of an investigation or inspection by a government entity (including federal, state, local, or foreign entities) or other oversight agency, or of adverse media attention related to laboratory performance;
• The laboratory finds itself the subject of a validation inspection.
• The laboratory discovers actions by laboratory personnel that violate national, state, or local regulations.
• Cooperation with COLA and U.S. Department of Health and Human Services when the laboratory is subject of a COLA or HHS complaint investigation or validation inspection.
• Have a written policy and procedure for investigating complaints that is incorporated into the Laboratory Quality Management Plan;
• Effectively demonstrate participation in COLA-accepted proficiency testing program;
• Availability, on a reasonable basis of the laboratorys annual proficiency testing results upon request by any person.
• Notify the COLA in writing of changes in location, ownership, directorship (copy of new directors curriculum vitae and organizational chart to be provided), insolvency, or bankruptcy. Notification must occur no later than 30 days prior to the change(s); or no later than two working days afterwards in the event of unexpected changes. Accreditation does not automatically survive these changes;
• The U.S. Department of Health and Human Services must also be notified.
• Promptly notify the COLA when there is change in the laboratorys test menu prior to beginning testing or when permanently or temporarily discontinuing some or all testing;

Experience

Required: - Proven experience in a leadership role within a clinical laboratory setting - In-depth knowledge of molecular biology, CGMP, laboratory techniques, and FDA regulations - Strong background in microbiology, histology, and scientific research - Proficiency in data collection and analysis methods

Nice-to-have: - Familiarity with advanced laboratory technologies and automation systems - Experience in developing and implementing quality control measures - Knowledge of emerging trends in clinical laboratory practices

Pay: $130,000-$145,000

Schedule: Full time

Location: Irvine, CA