Technical Operations Supervisor II in Louisville, Kentucky at HEALTHTRACKRX INC

HealthTrackRx is the nation’s premier molecular testing laboratory for infectious diseases, dedicated to delivering next-morning PCR results that empower providers and communities to make timely, precise treatment decisions. Test today, and get answers tomorrow with HealthTrackRx’s commitment to fast, reliable diagnostics for better health outcomes.

Job Summary:

• The Technical Operations Supervisor II is responsible for being the onsite resource for potential technical issues and is the go-to resource to provide lab personnel support. The Technical Operations Supervisor II is responsible for ensuring all training and competency assessments are current for all staff handling patient specimens. In collaboration with the Lab Director and Quality Assurance Department, will be responsible for ensuring all State and CLIA/CAP regulatory requirements are met. The Technical Operations Supervisor II is responsible for delivering timely results of all infectious disease testing with a goal of providing 100% accuracy.

Essential Responsibilities/Duties:

• Verification of all critical reagents, with adherence to CAP requirements for labelling and Quality Control, that requires all new lot numbers and new shipments to be evaluated before placing reagent into use for patient samples.
• Reviewing and assisting Lab Management and Quality Department with workflow updates and ensuring SOPs are up to date and implemented in real time for workflow processes.
• Adhere to the laboratory's quality control policies, quality control activities, and SOPs.
• Facilitate and ensure employees appropriate individual work output completed based on current metrics.
• Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.
• Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.
• Demonstrate proficiency while running KingFisher Flex, Veriti Pro, Accufill QuantStudio12K and QuantStudio5, while manually pipetting and preparing solutions.
• Performing specimen processing and PCR reactions as needed.
• Ability to perform basic accessioning in pre-analytical operations: requirements for Patient Identifiers (PID), auditing and communicating client manifest issues, identifying specimens categorized as non-compliant, acceptance/rejection of patient specimens, and creating cases for exceptions and send out orders.
• Responsible for adherence to annual Safety, Compliance, HIPPA training, and monthly CEU requirements.
• Resource management through ADP; approve PTO requests, approve timecards, complete employee performance review.

Additional Responsibilities which may be Assigned at the Discretion of the Laboratory Director:

• 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.
• Result submission and participation with an HHS/CAP/API approved proficiency testing program commensurate with the services offered.
• Responsible for performing validations and additional related responsibilities as required (i.e. validations, AMR, new lot verifications, internal audits, document control).
• Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.
• Assuring that all corrective and preventive actions are taken whenever test systems deviate from the laboratory's established performance specifications.
• Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, as distributed by the Quality Assurance Department
• Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently.

Qualifications:

• 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:
• Masters’s Degree in a chemical, biological, or clinical laboratory science is required.

• Knowledge of clinical laboratory services
• Technical knowledge to monitor lab operations
• Ability to communicate effectively both orally and in writing
• Ability work independently and strong attention to detail
• Strong Problem-Solving Skills
• Ability to troubleshoot and conduct root cause analysis

• 2 years previous supervisory experience required.
• 2 years training and experience in high-complexity testing in the respective specialty.  
• Comprehensive understanding of QA/QC to ensure precision and accuracy of results.
• Proficient in molecular laboratory techniques and processes, including but not limited to pipetting.
• Broad understanding of sterile technique, contamination control, and unidirectional workflow necessary for a PCR lab.
• Thorough understanding of quantitative PCR workflow and data analysis as it related to troubleshooting.
• Prior experience in, instrument verification and/or validations required.

• ASCP/AMT, or other organizations preferred unless required by the state in which the laboratory is located.