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Manager, Quality Control

Tempus

Tempus

Quality Assurance
Chicago, IL, USA
Posted on Thursday, June 13, 2024

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for a Manager who will be responsible for managing the daily lab quality operations at Tempus.

What you’ll do:

  • Build improvements and 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.
  • 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.
  • Lead team of supervisors, individual contributors, and mentor junior staff.
  • Track control performance trends and investigate incidents.
  • Review daily, weekly, and monthly QC results and determine the validity of results, perform follow-up as needed.
  • 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.
  • Collaborate with Supply Chain and Lab teams to ensure adequate supply of qualified reagents is available for clinical lab processing.
  • Coordinate workflows with clinical lab operations, supply chain, bioinformatics, and quality assurance.
  • Ensure that all new lots and shipments of reagents are qualified and appropriately labeled for clinical lab processing.
  • Maintain reagent qualification records and manage quality control of reagent inventory.
  • Provide technical direction and guidance to laboratory employees.
  • Ensure laboratory practices meet CAP/CLIA/NYSDOH/ISO regulations.
  • Adhere to safety and environmental requirements, including the appropriate disposal of excess or expired reagents.
  • Monitor reagent storage conditions and instigate investigations in response to any temperature excursions.

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 is highly desired
  • Impeccable attention to detail
  • Excellent communication skills
  • Thrives in a fast-paced environment
  • 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

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.