Senior Quality System Specialist
About The Position
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Position Summary: The Sr Quality Specialist plays an integral role on the Quality team and supports the company's compliance activities with the FDA Quality System Regulation and ISO 13485 as well as CLIA, CAP, and applicable state requirements. The Sr Quality Specialist works closely with a wide variety of departments to support quality activities and identify opportunities for continual improvement.
Requirements
- B.S. degree in a scientific discipline
- 5+ years of quality experience in the Life Sciences Industry
- Experience in compliance with quality standards in a regulated Molecular laboratory
- Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
- Ability to constructively challenge concerns and engage in transparent conversations
- Ability to work effectively in a team environment and build strong working relationships
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
- Proven attention to detail and accuracy
- Effective organizational skills
- High degree of initiative and self-motivation
- Drive for results and continual improvement - Ensure procedures and processes are in place that lead to the delivery of quality results and continually assess their effectiveness to drive continual improvement
- Experience with Microsoft Office suite and Internet for business use
Nice To Haves
- Experience with utilizing a Laboratory Information Management System is preferred
Responsibilities
- Manage all aspects of Guardant Health's non-conforming event system including corrective and preventative action program
- Manage the documentation and approval for all deviations
- Provide Quality new hire training on Quality processes
- Maintain all NCR, CAPA, and DAR records
- Create and maintain quality metrics required for management review
- Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company's QMS
- Represent Quality at cross functional meetings
- Support routine Quality processes such as document control, providing employee training, investigating non-conformances, and developing Quality metrics
- Ensure that all policies, procedures, and records are reviewed and approved
- Perform and document internal audits and makes recommendations for corrective actions
- Execute special projects as assigned
- Report and document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
