Quality Assurance (QA) 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).  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 Required Skills:  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 Some QA experience in a molecular testing laboratory (LDTs) is a plus Interest in obtaining Auditor certification is a plus CHI: $55,000-$70,000 The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. 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.