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.
• 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.

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