Supervisor, Lab Quality

Tempus AI•Chicago, IL

About The Position

The Supervisor, Lab Quality is responsible for maintaining CLIA, CAP, NYS-DOH, and FDA compliance for Tempus' clinical laboratory. The role oversees the QC and Facilities teams, supports laboratory quality processes, maintains reagent and equipment records, and coordinates laboratory facilities needs. The supervisor serves as a subject matter expert for quality processes, including during audits and inspections, and works with laboratory management, testing personnel, and other teams to ensure compliant operations.

Requirements

  • Bachelor of Science in medical technology, clinical laboratory science, chemical or biomedical engineering, or a physical or biological science.
  • At least 4 years of experience.
  • Highly organized and systematic, with superb attention to detail and the ability to complete tasks accurately.
  • Proven ability to learn new skills quickly and adapt smoothly to new processes.
  • Moderate experience with Microsoft Excel and/or Google Sheets.
  • Strong communication skills by email and phone, and interpersonal abilities with external providers and internal customers.

Nice To Haves

  • At least 7 years of clinical experience.
  • Experience in an FDA-regulated laboratory.
  • Experience in a CAP/CLIA-regulated laboratory.

Responsibilities

  • Oversee QC and Facilities teams by providing direction and mentorship, ensuring adequate staffing, and approving timecards.
  • Ensure new reagent lots and shipments are qualified and appropriately labeled for clinical laboratory processing.
  • Maintain reagent qualification records and manage quality control of reagent inventory.
  • Monitor critical QC metrics and respond to trends and issues.
  • Ensure equipment is properly maintained, IQ/OQ/PQ documentation is completed before use, preventive maintenance is completed, and service contracts are in place for capital instrumentation when required.
  • Assist in troubleshooting laboratory errors.
  • Help facilitate and implement corrective and preventive actions.
  • Serve as a subject matter expert for laboratory quality processes, including during audits and inspections.
  • Update SOPs and records in the document control system, including creating, revising, and reviewing internal SOPs and other quality documentation.
  • Interact with laboratory management and testing personnel to coordinate QC tasks.
  • Coordinate with other teams to ensure processes meet CLIA, CAP, NYS-DOH, and FDA requirements.
  • Oversee and maintain QC trackers and databases for reagents and equipment assets.
  • Monitor and maintain temperature-controlled storage and laboratory spaces to ensure equipment, samples, and reagents are stored properly.
  • Coordinate laboratory facilities tasks to ensure the laboratory has sufficient electrical and HVAC systems.

Benefits

  • Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical benefits, and other benefits depending on the position.
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