HealthTrackRx
Technical Operations Supervisor
The Technical Operations Supervisor has a senior-level role in ensuring the technical quality of all clinical diagnostic processes. This position will work closely with the Laboratory Director to participate directly in oversight of all diagnostic processes to ensure adherence to established quality and accreditation standards. The Technical Operations Supervisor is accountable for ensuring that all CLIA/CAP Regulatory Requirements, as they relate to technical processes, are met. Additional tasks include assistance in evaluation of alternate test systems, design and facilitation of test system validations and verifications, and implementation of various technical process improvements. Essential Responsibilities/Duties: Design validation experiments for new equipment and technologies as defined by the supporting Laboratory Directors, ensuring compliance with regulatory requirements and internal protocols. Perform data analysis for test system validations/verifications Draft required documentation for test system validation/verifications as defined by Laboratory Directors, including proposals, plans, and performance summaries Facilitate performance of validation/verification experiments by reviewing plans with Technical Staff and providing real-time oversight Present validation findings to laboratory administrators and quality assurance team. CLS Quality Oversight and Monitoring: Monitor performance of Clinical Laboratory Scientists and provide real-time coaching as it relates to test performance Provide feedback to Laboratory Supervisors and Laboratory Director of CLS technical performance Leading Root Cause Analysis of Non-conforming Events and Procedural Deviations in partnership with Quality Assurance Department, including the completion of CAPA documentation Continuous Process Improvement: Analyze quality metrics and KPIs to identify areas of process improvement within analytical operations and assist with implementation Participate in floor-level observations during working shifts to conduct process-layered audits and monitor for procedural adherence Maintain comprehensive documentation related to validation processes, equipment onboarding, and activities associated with the laboratory set up in compliance with regulatory requirements. Assist in the development and revision of standard operating procedures (SOPs) and work instructions related to technical processes. Maintenance of Regulatory Technical Requirements: Performance of various required instrument runs including lot verifications, instrument/method comparisons, AMR/Cut-off verifications Assessment of CLS technical competencies and submission of required paperwork to Quality Assurance Partner with Technical Training Team to establish training programs and aids are sufficient Maintenance of technical proficiencies for all current test systems May be required to assist with technical processing Must be accessible to testing personnel at all times to provide on-site, telephone, or electronic support to resolve technical problems in accordance with policies and procedures established by the Laboratory Director Accountable for result submission for HHS/CAP/CLIA/NYSDOH-approved proficiency testing and alternate assessment programs, as well as completed required associated documentation Performing required periodic audits as outlined by the Quality Management System Qualifications: Education: Doctoral degree in biological, laboratory or clinical sciences field, required for SDF Locations. Masters degree in biological, laboratory or clinical science fields, required for other locations (ATL, DFW & LAX). Competencies/Skills: Excellent written and verbal communication skills Ability to create and present presentations to key stakeholders Basic math skills: Ability to create and work with statistical data Moderate to advanced skill in Microsoft Office Products (Word, Excel, PowerPoint, Teams, SharePoint, etc.) Ability to perform, create and interpret statistical data for validations, correlations, etc. Ability to travel (~10%) Ability to multitask and manage multiple concurrent projects at the departmental level. Experience: 1-3 years prior clinical laboratory experience, required. Participation in CAP/CLIA inspections, required. Bench-level technical experience, required. Molecular Diagnostics experience in a CLIAcertified environment, required. Previous management experience, required. QuantStudio 12K experience, required. OpenArray experience, preferred. Certifications/Licenses: ASCP or applicable Quality Licensure (ASQ, Six Sigma, etc.) preferred.
The Technical Operations Supervisor has a senior-level role in ensuring the technical quality of all clinical diagnostic processes. This position will work closely with the Laboratory Director to participate directly in oversight of all diagnostic processes to ensure adherence to established quality and accreditation standards. The Technical Operations Supervisor is accountable for ensuring that all CLIA/CAP Regulatory Requirements, as they relate to technical processes, are met. Additional tasks include assistance in evaluation of alternate test systems, design and facilitation of test system validations and verifications, and implementation of various technical process improvements. Essential Responsibilities/Duties: Design validation experiments for new equipment and technologies as defined by the supporting Laboratory Directors, ensuring compliance with regulatory requirements and internal protocols. Perform data analysis for test system validations/verifications Draft required documentation for test system validation/verifications as defined by Laboratory Directors, including proposals, plans, and performance summaries Facilitate performance of validation/verification experiments by reviewing plans with Technical Staff and providing real-time oversight Present validation findings to laboratory administrators and quality assurance team. CLS Quality Oversight and Monitoring: Monitor performance of Clinical Laboratory Scientists and provide real-time coaching as it relates to test performance Provide feedback to Laboratory Supervisors and Laboratory Director of CLS technical performance Leading Root Cause Analysis of Non-conforming Events and Procedural Deviations in partnership with Quality Assurance Department, including the completion of CAPA documentation Continuous Process Improvement: Analyze quality metrics and KPIs to identify areas of process improvement within analytical operations and assist with implementation Participate in floor-level observations during working shifts to conduct process-layered audits and monitor for procedural adherence Maintain comprehensive documentation related to validation processes, equipment onboarding, and activities associated with the laboratory set up in compliance with regulatory requirements. Assist in the development and revision of standard operating procedures (SOPs) and work instructions related to technical processes. Maintenance of Regulatory Technical Requirements: Performance of various required instrument runs including lot verifications, instrument/method comparisons, AMR/Cut-off verifications Assessment of CLS technical competencies and submission of required paperwork to Quality Assurance Partner with Technical Training Team to establish training programs and aids are sufficient Maintenance of technical proficiencies for all current test systems May be required to assist with technical processing Must be accessible to testing personnel at all times to provide on-site, telephone, or electronic support to resolve technical problems in accordance with policies and procedures established by the Laboratory Director Accountable for result submission for HHS/CAP/CLIA/NYSDOH-approved proficiency testing and alternate assessment programs, as well as completed required associated documentation Performing required periodic audits as outlined by the Quality Management System Qualifications: Education: Doctoral degree in biological, laboratory or clinical sciences field, required for SDF Locations. Masters degree in biological, laboratory or clinical science fields, required for other locations (ATL, DFW & LAX). Competencies/Skills: Excellent written and verbal communication skills Ability to create and present presentations to key stakeholders Basic math skills: Ability to create and work with statistical data Moderate to advanced skill in Microsoft Office Products (Word, Excel, PowerPoint, Teams, SharePoint, etc.) Ability to perform, create and interpret statistical data for validations, correlations, etc. Ability to travel (~10%) Ability to multitask and manage multiple concurrent projects at the departmental level. Experience: 1-3 years prior clinical laboratory experience, required. Participation in CAP/CLIA inspections, required. Bench-level technical experience, required. Molecular Diagnostics experience in a CLIAcertified environment, required. Previous management experience, required. QuantStudio 12K experience, required. OpenArray experience, preferred. Certifications/Licenses: ASCP or applicable Quality Licensure (ASQ, Six Sigma, etc.) preferred.