Senior Quality Systems Specialist

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 Quality Specialist to join the QA team who will support all activities related to CAP/CLIA/NYS Licensure for our Clinical Laboratories.

Responsibilities

• Support the Clinical Laboratory to ensure CAP/CLIA/NYS/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 document control (MediaLab Modules) supporting CAP compliance such as Personnel Documentation, Compliance/CE, Inspection Proof and others as applicable.
• Author and reviews SOPs/Policies, verification/validation Protocols and Reports.
• Conduct laboratory walkthroughs and CAP self-inspections for the clinical laboratory. Lead inspection readiness efforts and host inspections as needed. 
• 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/NYSODH is highly desirable. Experience in the FDA regulated industry - medical devices or IVDs is a plus.

#LI-SH1