Senior Quality System Specialist

Company Description

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, visitguardanthealth.comand follow the company onLinked

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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.

• 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.

• 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
• Experience with utilizing a Laboratory Information Management System is preferred
• 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 elevate 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.

This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies. Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires.

At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need. Primary

Location:

Palo Alto, CA Primary Location Base Pay Range: $108,000 - $148,500 Other US Location(s) Base Pay Range: $91,800 - $126,225 If the role is performed in Colorado, the pay range for this job is: $97,200 - $133,650

Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.

Guardant Health is committed to…