Supervisor, Lab Quality

Tempus AI, Inc.; Chicago (IL); Presencial; USD 60 000 - 80 000; Tempo integral

Resumo da oferta

Tempus AI, Inc. is seeking a Lab Quality Supervisor to lead QC and facilities teams in a CLIA/CAP/NYS-DOH/FDA compliant clinical lab environment in Chicago, IL. The role focuses on reagent qualification, QC metrics, and audit readiness.

The candidate should bring 4+ years in a regulated lab, with strong organizational skills and experience with Excel/Sheets. Competitive salary and full benefits are offered.

Qualificações

• BS in medical technology, clinical laboratory science, chemical, biomedical engineering, physical or biological science.
• 4+ years of experience required; 7+ years of clinical experience preferred.
• Experience in FDA regulated lab preferred.
• Experience in CAP/CLIA regulated lab preferred.
• Great communication and interpersonal abilities for external providers and internal customers.

Responsabilidades

• Oversee QC and Facilities teams with direction and mentorship.
• Ensure reagents are qualified and properly labeled for clinical lab processing.
• Maintain reagent qualification records and QC of inventory.
• Monitor QC metrics, respond to trends and issues.
• Ensure equipment maintenance and IQ/OQ/PQ documentation.
• Assist in troubleshooting lab errors and corrective actions.
• Serve as SME for laboratory quality processes during audits and inspections.
• Update SOPs and records in the document control system.
• Coordinate QC tasks with lab management and testing personnel.
• Ensure processes meet CLIA/CAP/NYS-DOH/FDA requirements.

Formação académica

BS in medical technology, clinical laboratory science, chemical, biomedical engineering, physical or biological science

Ferramentas

Excel

Google Sheets

Descrição da oferta de emprego

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 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 Lab Quality Supervisor, who will be responsible for maintaining CLIA/CAP/NYS-DOH/FDA compliance for our clinical lab.

What You’ll Do:

• Oversee QC and Facilities teams by providing direction and mentorship, ensuring adequate staffing, and approving timecards.
• 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.
• Monitor critical QC metrics and respond to trends and issues.
• Ensure equipment is properly maintained, documentation records for IQ/OQ/PQs are completed prior to use, PMs are completed, and Service Contracts are in place for capital instrumentation when required.
• Assist in troubleshooting of lab errors.
• Help facilitate and implement corrective and preventative actions.
• Serve as subject matter expert for laboratory quality processes, including during audits and inspections.
• Update SOPs and records within the document control system, including creation/ revision/ review of internal SOPs and other quality documentation.
• Interact with lab management and testing personnel to coordinate QC tasks.
• Coordinate with other teams to ensure processes meet CLIA/CAP/NYS-DOH/FDA requirements.
• Oversee and maintain QC trackers and databases for reagents and equipment assets.
• Monitor and maintain temperature controlled storage and lab spaces to ensure equipment, samples, and reagents are being stored properly.
• Coordinate lab facilities tasks to ensure that the laboratory has sufficient electrical and HVAC systems in place.

Qualifications:

• BS in medical technology, clinical laboratory science, chemical, biomedical engineering, physical or biological science and 4+ years of experience required; 7+ years of clinical experience preferred.
• Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy.
• Proven ability to learn new skills quickly and adapt to new processes smoothly.
• Moderate experience with Microsoft Excel and/ or Google Sheets.
• Experience in FDA regulated lab preferred.
• Experience in CAP/CLIA regulated lab preferred.
• Great communication (email & phone) and interpersonal abilities for external providers as well as internal customers.

CHI/National: $60,000-$80,000 The expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience.

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

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.

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. 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.