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  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. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & 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 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.

Job Description

Essential Duties & Responsibilities:

  • Support routine Quality processes such as document control, providing employee training, investigating non-conformances, & developing Quality metrics
  • Provide day to day quality support for the clinical laboratory & manufacturing activities
  • Collaborate with various departments to drive process improvement initiatives
  • Create & maintain quality metrics required for management review and/or to report to senior management
  • Provide Quality Assurance (QA) oversight for the laboratory & represent work with cross functional teams to resolve discrepancies & drive to closure.
  • Develop & maintain organized records that demonstrate compliance to all company processes, regulations, & the company's QMS
  • Represent Quality at cross functional meetings
  • Ensure that all policies, procedures, & records are reviewed & approved
  • Perform & document internal audits & make recommendations for corrective actions
  • Assist with validation submissions & responses for state agencies
  • Execute special projects as assigned
  • Report & document all concerns of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
Qualifications
  • B.S. degree in a scientific discipline
  • 1-3 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 & 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 successfully balance & prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
  • 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
Additional Information

All your information will be kept confidential according to EEO guidelines.

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#GuardantHealth#PatientFirst#LiquidBiopsy#LUNAR#Eclipse#RealWorldEvidence#CDx#CompanionDiagnostics#biojobs#biotechjobs#biotechcareers#biocareers#pharmajobs#oncologyjobs#biotechbay #LI-CS1

 
 
 
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