Manager, Quality Control

Manager, Quality Control Tempus - 3.0 Research Triangle Park, NC Job Details Full-time 1 day ago Qualifications Team management Full Job Description 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. 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 Employee Health & 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 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. About Us Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company's first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives. Why Work Here? We're looking for people who can change the world. Who question the status quo and don't shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We're looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.