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/QC Specialist who will be responsible for monitoring Quality Assurance and Quality Control activities and support quality improvement initiatives to ensure that Tempus’ processes are safe, effective, appropriate, compliant, current, and adhered to by all Tempus staff. This role will report to the Quality and Compliance Manager.
What You’ll Do:
- Support the QA Team in maintaining Tempus’ state and federal licensure and CAP/CLIA/NYS/FDA regulatory compliance.
- Collaborate cross-functionally to support the maintenance and improvement of Tempus’ Quality Management System (QMS).
- Support, review, and approve documentation regarding deviations, root cause analyses, and corrective and preventive actions (CAPAs).
- Review executed batch records to ensure that product released by Tempus is in adherence with established written procedures and product specifications, and that all batch related deviations are closed prior to release of the batch.
- Identify errors or documentation deficiencies in the batch records and related documentation and effectively communicate them to the responsible individuals to have them resolved.
- Monitor and track pre-analytical, analytical, and post analytical performance and advises the QA Manager when performance standards are not met.
- Support quality audits as needed.
- Conveys QA/QC data and audit findings in a concise and professional manner.
- Writes and reviews procedures, verification/validation protocols, and reports.
- May be required to assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
- Other duties as assigned.
- 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.
- Bachelor’s degree required.
- Minimum of 4 years of related knowledge and experience. Experience with FDA medical device regulations, or related topics, is a plus.