Senior Clinical Quality Specialist - #100182
Date: 04/19/2022 18:30 PM
City: Redwood City, California
Contract type: Full Time
Work schedule: Full Day
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.
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.
Essential Duties and 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 training on Quality processes
- Maintain all Nonconformance, CAPA, and Deviation 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
- Ensure that all policies, procedures, and records are reviewed and approved
- 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 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.
Covid Vaccination Policy: Starting January 7, 2022, Guardant Health will require all employees to be fully vaccinated to either (a) establish that they have been fully vaccinated against COVID-19; or (b) request and obtain an approved exemption from Guardant’s COVID-19 U.S. Vaccination Policy as a reasonable accommodation, as consistent with applicable laws. An employee is considered fully vaccinated against COVID-19 two weeks after receiving the second dose of a two-dose vaccine or one dose of a single-dose vaccination. Acceptable vaccines are approved or under emergency use authorization by the U.S. Food and Drug Administration (FDA) and/or the World Health Organization (WHO). In addition, fully-vaccinated employees will be required to maintain their fully-vaccinated status under this policy by obtaining, if applicable, any FDA-approved boosters.
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 an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
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Please visit our career page at: http://www.guardanthealth.com/jobs/
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