Quality Assurance 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.

Responsibilities:

• Support Lead Auditor with audit functions
  • Participate in conducting internal audits under the direction of the Lead Auditor
  • Assist with completion of partnership pre-audit questionnaires
  • Oversee drafting of internal and external audit responses to closure
  • Administrative audit functions as needed
  • Lead partnership/client audits.
  • Communicate with partners as needed
• Assist with client pre-qualification questionnaires regarding quality assurance (QA) and the quality management system (QMS).  
• Assist with completion of Declaration of Conformity (EC DoC) of products
• Communication with Tempus’ Notified Body as needed
• Comply with documented Quality Management System procedures
• Completion of assigned training on time
• Perform other duties and projects as assigned
• Review QMS documentation against applicable regulations for international compliance
• Remain up to date with applicable regulations to communicate changing requirements to Management
• Assist with inspection readiness efforts and external audits
• Offer improvement strategies to existing processes
• Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections. 

Required Skills:

• Superb organizational and follow through skills
• Strong interpersonal skills in the areas of written and verbal communication
• Must be creative, flexible, and able to prioritize and handle multiple projects concurrently
• Must be self-motivated and have the ability to work with minimal supervision
• Minimum of 4 years of QMS experience in the FDA regulated industry - medical devices or IVDs
• Bachelor’s degree required preferably in a life science discipline

Preferred Experience

• Some QA experience in a molecular testing laboratory (LDTs) is a plus
• Interest in obtaining Auditor certification is a plus

#LI-SH1

#LI-Hybrid