Quality Assurance; QA Specialist

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

• 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

Salary Range: $55,000–$70,000 (Illinois); may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience.

Benefits 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.