Director, Laboratory

SUMMARY:
The Laboratory Director is responsible for the overall technical, scientific, and administrative oversight of the laboratory. This position ensures the accuracy, reliability, and timeliness of laboratory services while maintaining full compliance with regulatory and accreditation requirements. The Laboratory Director oversees quality assurance and quality control programs; validates and implements new tests, methods, and instrumentation; and ensures competency and training standards are consistently met.

ESSENTIAL FUNCTIONS:

• Selects test methodologies appropriate for the clinical use and scope of the laboratory's test menu.
• Verifies, validates, and approves test procedures and establishes laboratory performance criteria, including accuracy, precision, reportable ranges, and reference intervals.
• Develops, implements, and monitors a comprehensive quality control (QC) program appropriate for all testing performed.
• Establishes acceptable levels of analytic performance and ensures they are maintained throughout all phases of testing.
• Ensures patient test results are released only when all corrective actions have been completed and systems are functioning within specifications.
• Ensures compliance with all applicable federal, state, and accreditation requirements.
• Provides oversight and resolution of technical problems; ensures appropriate remedial actions are taken when test systems deviate from expected performance.
• Reviews QC, QA, proficiency testing, maintenance, calibration, and troubleshooting records to ensure accuracy and regulatory compliance.
• Identifies root causes of system failures and implements sustainable corrective and preventive actions.
• Helps organize and direct daily laboratory operations to ensure efficient workflow and timely results.
• Ensures all laboratory procedure, specimen handling, processing, analysis, reporting, and record retention are followed consistently.
• Conducts chemical and biological analyses, including blood, urine, and other body fluids, using microscopy, automated analyzers, and mass spectrometry systems.
• Operates and maintains laboratory instruments; ensures documentation of maintenance, calibration, and performance checks.
• Performs urine toxicology confirmation analysis and interprets LC/MS/MS data.
• Validates confirmatory assays, reagents, calibrators, and control materials according to QA standards.
• Ensures adherence to universal precautions and biosafety protocols to protect staff and maintain a safe laboratory environment.
• Ensures all quality control programs and documentation meet regulatory and accreditor standards.
• Performs daily troubleshooting and maintenance on assigned instruments.
• Participates in audits, inspections, and emergency preparedness activities.
• Perform other related tasks as needed.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Proficiency in mass spectrometry software, LC/MS/MS, and/or chemistry analyzers.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Familiarity in clinical specimen collection, processing, and general laboratory techniques.
• Ability to interpret complex toxicology and mass spectrometry data.
• Strong communication, and interpersonal skills, ability to collaborate effectively with partners.
• Ability to work independently with minimal supervision.
• Strong attention to detail, analytical thinking, and problem-solving abilities.

EDUCATION AND EXPERIENCE:

• Bachelor's degree in Clinical Laboratory Science or related field or;
• Four (4) years of laboratory experience in lieu of education
• Five (5) years of laboratory services experience in a healthcare environment