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Guardant Health // rare-cell diagnostics
 
, Full Time       Posted: Wednesday, March 04, 2020
 
   
 
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JOB DETAILS
 

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.

In pursuit of our goal to manage cancer across all stages of the disease, Guardant Health has launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.

Job Description

The Senior eQMS Administrator plays an integral role on the Quality team & supports the company's compliance activities with the FDA Quality System Regulation & ISO 13485 as well as CLIA, CAP, & applicable state requirements. The focus of this position is the day to day management of, maintenance of, & the long-term strategy for the electronic Quality Management System.

Essential Duties & Responsibilities:

  • Administrator for electronic Quality Management System (eQMS)
  • Responsible for vendor relationship
  • Responsible for lifecycle management, maintenance & configuration of eQMS, in accordance with change control processes
  • Interface with area owners to develop & maintain the system
  • Gather user & business needs & 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 & monitor system performance & quality metrics, as required Develop & maintain organized records that demonstrate compliance to all company processes, regulations, & the company's QMS
  • Represent Quality at cross functional meetings
  • Execute special projects as assigned

Qualifications
  • 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 & written communication skills & ability to share & receive information from all levels of the organization throughout various departments
  • Ability to constructively challenge concerns & engage in transparent conversations
  • Ability to work effectively in a team environment & build strong working relationships
  • Ability to identify, analyze & solve problems with minimal direction & escalate concerns to management
  • Proven attention to detail & accuracy
  • Effective organizational skills
  • High degree of initiative & self-motivation
  • Drive for results & continual improvement - Ensure procedures & processes are in place that lead to the delivery of quality results & continually assess their effectiveness to drive continual improvement
  • Experience with Microsoft Office suite & Internet for business use

Work Environment:

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

Additional Information

Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & 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 & 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 & how it is used, please review ourPrivacy Notice for Job Applicants.

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