QA Auditor at Tempus
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 QA Auditor who will be responsible for independently performing audits of a broad range of records and reports and inspections of a variety of processes to assure compliance with applicable regulatory requirements, standards, and corporate policies and procedures. This role will report to the Quality and Compliance Manager.
What You’ll Do:
- Conduct complex internal and/or external audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines and/or client contractual obligations.
- Perform laboratory walkthroughs of designated laboratory areas and applicable 3rd party vendors.
- Plan, execute, and follow up on audits, including preparing audit reports and documenting findings.
- Work with various departments in order to resolve compliance issues, provide recommendations for corrective actions; maintain continuous communication throughout problem resolution process.
- Provide training as needed regarding compliance issues, regulation changes and criteria across the site.
- Support and maintain audit files and ensure proper documentation standards are adhered to.
- Assists with preparation for and hosting of client audits and/or regulatory inspections.
- Coordinates the responses and corrective actions associated with the audits.
- Other duties as assigned.
- Bachelor's degree with minimum of 5 years of experience.
- Working experience in a Quality environment with expertise, knowledge, and experience in GMP, GLP, GCP, and 21 CFR Part 11. Experience with CAP/CLIA is also preferred.
- Must have understanding of internal auditing standards and risk assessment practices.
- Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve.
- Proven ability to exercise good judgment and effectively balance work activities and changing priorities.
- Strong organization, problem-solving, critical thinking and decision-making skills.