Senior Quality Assurance Specialist, RTP

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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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.