Quality Assurance (QA) Specialist

Tempus AI•Chicago, IL

5h•Remote

About The Position

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.

Requirements

Superb organizational and follow through skills
Willingness to learn applicable quality standards, regulations, and internal procedures.
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 1 year of QMS experience in the FDA regulated industry - medical devices or IVDs
Bachelor’s degree required preferably in a life science discipline
Exposure to internal audits, external audits, and inspections

Nice To Haves

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

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).
Communication with Tempus’ Notified Body as needed
Comply with documented Quality Management System procedures
Completion of assigned training on time
Review QMS documentation against applicable regulations for international compliance
Remain up to date with applicable regulations to communicate changing requirements to Management
Track corrective and preventive actions (CAPAs), deviations, and follow-up activities related to audit outcomes
Assist with inspection readiness efforts and external audits
Help identify opportunities for process improvement related compliance and inspection readiness.
Managing and hosting external audits including regulatory inspections and CAP/CLIA Inspections.
Collaborate with cross-functional teams to collect documentation and support compliance activities.
Perform other duties and projects as assigned and ability to be flexible in supporting various quality system areas