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 Senior Quality Assurance Specialist to join the QA team who will
support all activities related to the quality management system for our RTP Laboratory.
Responsibilities
- Support the Clinical Laboratory to ensure CAP/CLIA/FDA regulatory compliance in all
aspects of laboratory operations. - Maintain CLIA certification, CAP accreditation and State licensure for the clinical
laboratory as required. - Lead, coordinate and support various QA activities such as:
- Maintenance of training plans and training records, including job descriptions and
CVs - Record Retention for Lab Documents including onsite and offsite storage
management. - Act as Administrator of multiple MediaLab Modules supporting CAP compliance
such as Personnel Documentation, Compliance/CE, Inspection Proof and others
as applicable.
- Maintenance of training plans and training records, including job descriptions and
- Author and reviews SOPs/policies, as well as verification/validation plans and reports.
- Conduct laboratory walkthroughs and CAP self-inspections for the clinical laboratory. Lead inspection readiness efforts and host inspections as needed.
- Track proficiency testing order, participation and performance.
- Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues.
- Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
- Participate in process improvements to the quality management system framework by helping identify areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
- Perform other job-related duties, as assigned.
Required Qualifications
- Bachelor’s degree required
- Minimum of 4+ years of related knowledge and experience
- Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy Strong interpersonal skills in the areas of written and verbal communication
- Self-motivated, organized, able to prioritize and organize time effectively
- Experience working with individuals to perform root cause investigations and to implement effective corrective actions
- Previous experience in a clinical lab regulated by CAP/CLIA is highly desirable. Experience in the FDA regulated industry - medical devices or IVDs is a plus.
#LI-GL1#LI-Hybrid
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.
Additionally, for remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
What the Team is Saying
What We Do
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make near real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics.
The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.
Why Work With Us
We're looking for those who challenge the status quo. For the builders who are never done building and the learners who are never done learning. We're looking for unwavering commitment and undying curiosity. We're looking for the smartest people on the planet to attack one of the most challenging problems mankind has ever faced.
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Tempus AI Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Most of the team follows a hybrid policy, with some roles allowing for a fully remote arrangement and some roles being onsite only.
