CLINICAL LABORATORIES MANAGER (50080426)

Job Role Summary

The Manager, Clinical Laboratories, is responsible for overseeing the operations of four CLIA clinical laboratories within the Marion County Public Health Department. This role involves managing laboratory staff, ensuring compliance with regulatory standards, and developing policies and procedures to enhance laboratory efficiency and quality. The Manager also coordinates training, establishes performance metrics, and collaborates with public health officials to support community health initiatives.

Must meet requirements to serve as Technical Supervisor as described in 42 CFR 493.1451 - Technical supervisor responsibilities for the following laboratory areas:

Bacteriology

Microbiology

Virology

Syphilis serology

General Immunology

Toxicology

Parasitology

Essential Duties

1. Administrative Oversight 30%

• Supervise daily operations in the clinical laboratory, including testing, workflow, and staffing.
• Manage laboratory staff by hiring, training, scheduling, and evaluating performance.
• Ensure compliance with policies, procedures, and regulations.

 2. Technical Supervision (35%)

• Oversight of Test Performance:Ensure all laboratory tests are accurate, timely, and efficient. Review test results, quality control data, and instrument logs for accuracy.
• Method Validation and Verification: Oversee the testing and approval of new testing methods, reagents, and tools to meet standards.
• Troubleshooting and Problem Resolution:Investigate and fix technical problems or equipment failures. Document any corrective actions taken for errors or issues.
• Quality Control (QC) and Quality Assurance (QA): Approve QC data to confirm performance, notice trends, and improve processes based on findings. Keep required records (e.g., QC logs, maintenance logs, and proficiency test results).
• Proficiency Testing (PT):Ensure participation in required PT programs. Review and evaluate PT results and take action when necessary.
• Instrument and Equipment Oversight: Approve and track maintenance schedules for equipment, including calibration and service checks.

3. Training and Competency (15%)

• Train staff on proper testing procedures, safety measures, and quality systems.
• Test and document the competence of staff for testing tasks.
• Ensure all staff follow Standard Operating Procedures (SOP) and regulations.

Associated Job Duties

4. Policy, Procedure, and SOP Management (5%)

• Develop, update, and maintain technical procedures and SOPs for all clinical testing areas.
• Ensure procedures align with manufacturer recommendations, best practices, and regulatory standards.

5. Performance Metrics (5%)

• Establish and monitor key performance indicators (KPIs) for laboratory operations, ensuring continuous improvement and accountability.
• Analyze laboratory performance data and implement strategies to enhance efficiency and quality of services.

6. Inventory Management (5%)

• Ensure materials and equipment are ordered and inspected and detailed and accurate inventory of supplies are maintained

7. Team Collaboration (5%):

• Collaborate with public health officials, healthcare providers, and other divisions within MCPHD to support public health initiatives and enhance laboratory services.
• Work closely with cross-functional teams to align laboratory objectives with overall health department goals.
• Participates in public health emergency preparedness exercises and in the response to public health emergencies, as directed.
• Participates in a minimum of two H.O.P.E. events totaling a minimum of eight (8) hours annually.

 This job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.  The employee may be asked to perform other duties as needed to support departmental and organizational goals.

Qualifications

• Required: Master’s degree in chemistry, biology, microbiology, medical technology, or Public Health.
• Required: 3-5 years of supervisory experience in a clinical laboratory setting.
• Required: 5-8 years of technical laboratory experience.  

Licenses/Certifications Required

• Required Certification: Medical Technologist (ASCP or AMT), Clinical Laboratory Technologist (NCA), or equivalent certification.
• Required to meet 42 CFR § 493.1449 Standard, Technical Supervisor Qualifications/Certification  

Knowledge, Skills & Abilities

• Extensive understanding of microbiology, molecular biology, hematology, and chemistry principles.
• In-depth knowledge of laboratory accreditation standards and regulatory guidelines (CLIA).
• Familiarity with quality control measures, laboratory information management systems preferred (LIMS), and safety protocols.
• Understanding of laboratory budgeting and resource management.
• Technology Proficiency: Strong familiarity with laboratory software applications, data analysis tools, and modern laboratory equipment.
• Strong leadership skills with the ability to mentor and develop staff.
• Excellent problem-solving abilities and decision-making skills.
• Effective communication skills for liaising with internal teams and external stakeholders.

Working Environment

• Primarily in a laboratory setting with exposure to hazards.
• Tasks may require standing for long periods and lifting supplies up to 35 pounds.