The Technical Operations Supervisor II is responsible for providing technical leadership and operational oversight for the laboratory while serving as the primary onsite resource for troubleshooting laboratory processes, instrumentation, workflow, and technical issues. This role provides daily guidance and support to laboratory personnel while ensuring accurate, timely, and compliant patient testing. In collaboration with the Laboratory Director, Quality Assurance, and laboratory leadership, the Technical Operations Supervisor II ensures compliance with all CLIA, CAP, state, and company regulatory requirements. The Technical Operations Supervisor II is responsible for maintaining laboratory quality systems, overseeing staff training and competency, driving productivity and workflow efficiency, and ensuring the delivery of accurate patient results while promoting a culture of operational excellence and continuous improvement.
- Serve as the primary onsite technical resource for laboratory personnel by troubleshooting instrumentation, laboratory processes, workflows, and testing issues.
- Remain accessible to testing personnel through onsite, telephone, or electronic communication to resolve technical issues in accordance with Laboratory Director policies.
- Investigate technical issues and implement corrective and preventive actions (CAPA) when testing systems deviate from established performance expectations.
- Perform and oversee, as applicable:
- Method validations & comparisons
- Instrument verifications
- Analytical Measurement Range (AMR) studies
- New reagent lot verifications
- Internal audits
- Document control activities
- Verify laboratory test procedures and establish laboratory test performance characteristics in collaboration with the Quality Assurance Department.
- Verify all critical reagents in accordance with CAP requirements, including evaluation of all new lot numbers and reagent shipments before use in patient testing.
- Perform specimen processing, as needed & maintain proficiency.
- Demonstrate proficiency in operating laboratory instrumentation.
- Ensure compliance with all CLIA, CAP, state, NYSDOH (where applicable), OSHA, HIPAA, and company regulatory requirements & participate in relevant proficiency testing programs.
- Adhere to and enforce laboratory quality management systems, quality control policies, standard operating procedures (SOPs), and safety requirements.
- Partner with Laboratory Management and Quality Assurance to review, revise, and implement SOPs and workflow improvements in real time.
- Support internal audits, regulatory inspections, corrective actions, preventive actions, and continuous quality improvement initiatives.
- Ensure all laboratory documentation is accurate, complete, and maintained in accordance with regulatory requirements.
- Supervise daily laboratory operations while promoting quality, accountability, teamwork, and continuous improvement.
- Evaluate and document employee competency to ensure staff maintain proficiency in performing laboratory testing and reporting accurate results.
- Monitor laboratory productivity, turnaround times, staffing levels, and workflow metrics to ensure operational goals are achieved.
- Conduct employee performance evaluations and provide ongoing coaching and performance feedback.
- Manage workforce resources through ADP, including approving timecards, PTO requests, attendance, and other workforce documentation.
- Ensure staff completes required annual Safety, Compliance, HIPAA, and monthly continuing education requirements.
- Monitor workflow efficiency and identify opportunities to improve quality, productivity, turnaround time, automation, and customer service.
- Collaborate with laboratory leadership on implementation of new instrumentation, assays, workflow enhancements, and process improvements.
- Participate in root cause analyses and implementation of corrective action plans.
- Assist with laboratory expansions, validations, special projects, and implementation of new testing platforms.
- Maintain effective communication across departments to support operational success.
- Perform other duties assigned by the Laboratory Director.
Qualifications
Education
Clinical testing personnel must possess a current license issued by the state in which the laboratory is located, if such licensing is required; and meet the following educational requirements:
- Master’s Degree in a chemical, biological, or clinical laboratory science is required.
Experience
- 2-years of previous supervisory experience required.
- 6-years of experience in high/moderate-complexity testing in the respective specialty.
- Experience performing method validations, instrument verifications, troubleshooting, and implementation of corrective actions.
- Comprehensive understanding of laboratory Quality Assurance (QA) and Quality Control (QC) principles.
- Relevant experience across clinical laboratory disciplines.
- Experience with regulatory compliance, including CLIA, CAP, and applicable state requirements.
Certifications/Licenses
- MLT, ASCP, MLS, AMT, or equivalent national certification preferred unless certification is required based on the specific clinical testing performed.
- State licensure required where applicable.