Senior Operations Quality Associate 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.
The Sr Operations Quality Associate will ideally have experience in the areas of FDA QSR (21 CFR 820), and ISO 13485. The Sr Operations Quality Associate should have previous exposure to CAP/CLIA, NYS requirements as the Laboratory develops, validates and performs Lab Developed Test (LDT) assays. The Sr Operations Quality Associate will participate in the following activities; batch review, material receipt and disposition, supplier quality activities, change controls, product quarantine activities, non-conformance reporting/issue resolution, root cause analysis, record handling, routine QA inspections of the laboratories, and QA approval of equipment validation & maintenance.
Schedule: Day Shift - Mon-Fri
- Day to day Quality Assurance lab support as needed
- Work with R&D and Laboratory Operations personnel to ensure compliance to product and process control standards as required by FDA 820.70.
- Support Process Validation activities and quality activities associated with equipment validation
- Approve for Quality Assurance all laboratory maintenance data sheets
- Provide quality support for the Equipment Calibrations and Maintenance.
- Record Handling and Retention Activities; maintaining all pertinent laboratory quality records.
- Responsible for incoming/receiving activities; Dispositions, Incoming Material Specification documentation, SCARs, Final Release, Quarantining, Inventory Control
- Responsible for performing Product Quarantine/MRB activities, including initiation and release.
- Performs Quality review for correctness and completeness on assigned in-process documentation to support QA release decisions/activities, including DHR/batch-record review.
- Support in-process QC activities, and final product release.
- Support the Change Management process, including reviewing and approving change controls for process and/or product. Ensure Change implementation and follow-up for effectiveness of change
- Participate in Laboratory Non-conformance event reporting. Responsible for Disposition activities for non-conforming products, including device and/or incoming materials and reagents.
- Participate in laboratory issue management activities requiring quality assurance approval and investigative support
- Participates in Internal and External Quality System Audits as required.
- Support supplier quality by gathering supplier and material metrics
- Participate in CAPA investigations and root cause analysis as required.
- Ensures all required documentation is included in records and that the documentation is accurate
- 2+ years of experience in the Medical Device/Pharmaceutical regulated industry in a quality assurance or quality control role.
- Bachelor's Degree is preferred
- Demonstrate working knowledge laboratory validation experience
- Experience with statistical analysis and application of statistical methods.
- Excellent oral and written communication, organizational, and skills are required.
- Proficient in MicroSoft Office (Word, PowerPoint, Excel, etc.).
- Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
- Ability to manage multiple tasks with limited supervision.