- Responsible for processing and managing issues/incidents that include deviations, NCs, and CAPAs, as well as ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
- Participate in process improvements to the issue/incident reporting framework by helping identify areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
- Collaborate with Regulatory on appropriate health authority reporting, as necessary.
- Assist in NC/CAPA activities, including investigations, root cause analysis, effectiveness verification, and closure by establishing cross-functional relationships and collaborations with functional owners.
- Drive ownership of issues/incidents to lead to final resolution and closure by providing training and guidance to owners.
- Responsible for assisting in activities to ensure departmental goals for deviations, NC and CAPA processes are achieved.
- Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues
- Participate if needed as a NC and CAPA subject matter expert during internal and external audits.
- Lead and/or support other duties as assigned.
- Bachelor's Degree in Engineering or Science field.
- 3+ of QA experience in a clinical laboratory/medical device/Diagnostic company, working on deviations, Nonconformances and CAPA processes.
- Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
- QA experience in a clinical molecular testing laboratory (LDTs) is required.
- Working knowledge of the deviations, NC and CAPA processes.
- Strong communication (written and verbal), influencing, negotiating and collaboration skills.
- Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
- Ability to manage multiple tasks with limited supervision.
- Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
- Ability and willingness to work independently and take initiative to ensure timely action on issues.
- This will be an on-site position.
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Senior Specialist, QA - Chicago, United States - Tempus
Description
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 Senior Quality Assurance Specialist plays an integral role in supporting quality activities related to incidents and issues, including deviation, nonconformances (NC) and corrective and preventive actions (CAPA) in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.
Responsibilities include the following. Other duties may be assigned.
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.
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