Position Summary
The Laboratory Manager oversees the daily operations, quality, compliance, staffing, and administrative functions of the clinical laboratory for an Endocrinology Private Practice. This position ensures accurate and timely testing, maintains CLIA and OSHA compliance, manages laboratory personnel and resources, oversees the Download Department, and works closely with the Operation’s Manager, Practice Administrator and designated CLIA Laboratory Director/Medical Director.
Essential Responsibilities
Laboratory Operations & Quality
- Oversee specimen collection, processing, testing, result reporting, and daily laboratory workflow.
- Ensure waived and non-waived testing is performed according to approved SOPs, manufacturer requirements, and applicable regulatory standards.
- Develop and maintain laboratory policies, procedures, logs, forms, quality control (QC), quality assurance (QA), and proficiency testing processes.
- Review QC, maintenance, calibration, testing, and corrective-action documentation; investigate and resolve discrepancies, unusual results, equipment issues, and workflow problems.
- Monitor laboratory performance, turnaround times, service quality, and opportunities for process improvement.
Compliance & Safety
- Maintain required CLIA documentation, certificates, licenses, permits, and inspection-readiness records.
- Ensure compliance with applicable CLIA, OSHA, HIPAA, safety, manufacturer, and accreditation requirements.
- Coordinate laboratory inspections, audits, and corrective actions with the Laboratory Director/Medical Director and practice leadership.
- Maintain chemical inventory, Safety Data Sheets (SDS), safety inspections, and appropriate handling and disposal procedures for specimens, reagents, sharps, and biohazardous materials.
- Stay current on regulatory changes and implement required updates to laboratory policies, procedures, training, and documentation.
Staff Management & Competency
- Train, schedule, supervise, coach, and evaluate laboratory staff in collaboration with Human Resources and practice leadership.
- Oversee the Download Department, including daily workflow, staffing, training, performance, and coordination of A1C testing, pump/CGM downloads, and related patient-care support.
- Maintain required staff credential, training, and competency records and ensure personnel complete required initial and ongoing competency assessments.
- Coordinate CLIA-required competency activities with appropriately qualified personnel, including the Technical Consultant and Laboratory Director when required.
- Address employee performance and disciplinary matters in coordination with Human Resources and promote a professional, collaborative, and safety-focused work environment.
Equipment, Supplies & External Services
- Oversee laboratory equipment maintenance, calibration, troubleshooting, repairs, service contracts, and return-to service documentation.
- Manage laboratory supplies, reagents, inventory controls, purchasing, and vendor relationships; evaluate and recommend new equipment and technology.
- Coordinate LIS functionality, data integrity, system checks, backup/recovery, and related technology needs with IT and vendors.
- Serve as the operational liaison with reference laboratories and contracted specimen/phlebotomy services; monitor quality, turnaround times, and issue resolution.
- Coordinate vaccine ordering and inventory controls when assigned to the laboratory function.
Financial & Administrative Responsibilities
- Participate in laboratory budgeting and monitor volume, productivity, expenses, staffing, and resource utilization.
- Identify cost-saving opportunities while maintaining quality and patient safety.
- Work with Billing and other departments to resolve laboratory charge, insurance, or workflow issues.
- Collaborate with clinical and administrative leadership on laboratory performance, organizational initiatives, and department goals.
