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Staff eQMS Administrator

Company: Guardant Health
Location: Redwood City
Posted on: February 21, 2021

Job Description:

Company DescriptionGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360-- and GuardantOMNI-- , for advanced stage cancer patients, which fuel its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection. Since its launch in 2014, Guardant360-- has been used by more than 7,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.Job DescriptionThis role works out of our Headquarters in Redwood City, CA. Due to the Covid 19 Pandemic Guardant Health has temporarily classified this role as 'working from home status', scheduled to return onsite at HQ when it is determined safe to do so.The Staff eQMS Administrator 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 focus of this position is the day to day management of, maintenance of, and the long-term strategy for the electronic Quality Management System.Essential Duties And ResponsibilitiesAdministrator for electronic Quality Management System (eQMS)* Responsible for vendor relationship* Responsible for lifecycle management, maintenance, configuration and architecture of eQMS, in accordance with change control processes* Interface with area owners to develop and maintain the system* Gather user and business needs and translate into requirements to develop / implement solutions* Point of contact for internal technical support* Work cross functionally to ensure the eQMS continues to meet the need of the organization* Create, maintain and monitor system performance and quality metrics, as required Develop and maintain organized records that demonstrate compliance to all company processes, regulations, and the company's QMS* Represent Quality at cross functional meetings* Execute special projects as assignedQualifications* Qualifications:* B.S. degree in a scientific discipline* 13+ 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 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 useAdditional InformationWork EnvironmentEmployee 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.To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.

Keywords: Guardant Health, Redwood City , Staff eQMS Administrator, Other , Redwood City, California

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