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Manager, Quality Control

Tempus

Tempus

Quality Assurance
Durham, NC, USA
Posted on Tuesday, July 9, 2024

Passionate about making a difference in the world of cancer genomics?

With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings. We are looking for a Manager who will be responsible for managing the daily lab quality operations at Tempus.

What you’ll do:

  • Manage reagent production and quality control operations to support lab testing, including but not limited to, reagent testing, positive control monitoring, planning reagent production/aliquoting, and setting testing criteria for new reagents.
  • Collaborate with Supply Chain and Lab teams to ensure adequate supply of qualified reagents are available for clinical lab processing.
  • Maintain reagent qualification records and manage quality control of reagent inventory.
  • Coordinate and optimize QC workflows with clinical lab operations, supply chain, bioinformatics, and quality assurance for existing and new assays
  • Monitor reagent storage conditions and instigate investigations in response to any temperature excursions.
  • Provide coverage and support for equipment and facilities quality control operations, including, but not limited to, ensuring the completion of IQOQs, PQs, PMs, calibrations, maintenance of SOPs, repairs, and regular maintenance, as needed.
  • Oversee and ensure safety and environmental requirements are upheld, in conjunction with Facilities and Safety Coordinator, including the appropriate disposal of excess or expired reagents and other hazardous waste.
  • Lead team of supervisors, individual contributors, and mentor junior staff; provide technical direction and guidance to laboratory employees.
  • Track control and probe performance trends and investigate incidents.
  • Review daily, weekly, and monthly QC results and determine the validity of results, perform follow up as needed.
  • Compile and present QC metrics to management during monthly meetings.
  • Troubleshoots and ensures corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
  • Participate in internal and external audits as subject matter expert for QC workflows.
  • Ensure laboratory practices meet CAP/CLIA/ISO/OSHA regulations.

Qualifications:

  • MS or BS in medical technology, clinical laboratory science, chemical, physical or biological science and at least 7 years of experience
  • Experience supervising others in a cGMP/ISO or CLIA/CAP high-complexity laboratory
  • Experience with Next-Generation sequencing and molecular testing methods
  • Familiarity with lean manufacturing and acceptance sampling techniques highly desired
  • Impeccable attention to detail
  • Ability to develop and implement strategic plans
  • Excellent communication skills in collaboration with cross functional stakeholders
  • Thrives in a fast-paced environment demonstrating and ability to adapt to changing circumstances and project priorities
  • Strong leadership abilities with high standards of personal and professional integrity
  • Self-driven and works well in an interdisciplinary team with minimal direction
  • Strong desire to build products that will save lives and change the course of cancer

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We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.