Supervises laboratory QC and facilities teams while maintaining CLIA, CAP, NYS-DOH, and FDA compliance. Responsibilities include reagent qualification, inventory quality control, QC metrics monitoring, equipment maintenance and qualification, troubleshooting, CAPA implementation, SOP and document control, audit support, database and tracker maintenance, temperature-controlled storage, and coordination of laboratory facilities requirements.
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 AI Cambridge, Massachusetts, USA Office
Tempus AI Boston - Tempus Office Office
Our Cambridge office is a co-working space right in the heart of Kendall Square, surrounded by restaurants, cafés, and easy access to the Charles River and nearby transit.
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