Passionate about making a difference in the world of cancer genomics?
With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings.
We are looking for a QA Auditor who will be responsible for independently performing audits of a broad range of records and reports, as well as representing Tempus during third party inspections, to assure compliance with applicable regulatory requirements, standards, and corporate policies and procedures. They will oversee all internal, customer, and supplier audits from preparation to closure. This role will report to the Quality and Compliance Manager.
What You’ll Do:
- Lead complex internal and external audits and inspections of Tempus’ 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 internal audits, including preparing audit reports and documenting findings.
- Work with various departments in order to resolve compliance issues, provide recommendations for corrective actions, and maintain continuous communication throughout problem resolution process.
- Support and maintain audit files and ensure proper documentation standards are adhered to.
- Oversee and assist with preparation for and hosting of client audits and/or regulatory inspections.
- Coordinates audit responses and corrective actions.
- Supports the supplier qualification programs.
- Assist with completion of other QA requirements as assigned, including but not limited to: Developing QA SOPs and /or programs ensuring conformance to regulatory requirements and best practices of QA or other department’s SOPs; and training as needed regarding compliance issues, regulation changes and criteria across the site.
- Must have a Bachelor's degree with a minimum of 5 years of experience.
- Working experience in a Quality environment with expertise, knowledge, and experience in GMP, GLP, GCP, GDP, and 21 CFR Part 11. Experience with CAP/CLIA is also preferred.
- Strong knowledge of quality and compliance in a regulated GxP/QMS environment.
- Certified Quality Auditor (CQA) Certification or Lead Auditor certification for applicable regulations (i.e. ISO 9001, ISO 13485) is required.
- Must have an 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.
- Position will be office based in Chicago, IL.