Events  Classes  Deals  Spaces  Jobs 
    Sign in  
  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

The Sr Quality Specialist 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 Sr Quality Specialist works closely with a wide variety of departments to support quality activities & identify opportunities for continual improvement.

Essential Duties & Responsibilities:

  • Responsible for implementation & maintenance of the internal audit program.
  • Responsible for creating annual internal audit schedule, developing internal audit plans & coordinating activities with cross-functional teams
  • Function as a lead auditor for internal audits & perform audits to ensure compliance to internal & external requriements
  • Provide recommendations for continuous improvement to strengthen the internal processes & structure
  • Document audit findings & monitor corrective actions associated with the audit findings until closure
  • Conduct re-audits as necessary to address identified compliance gaps & to follow up on corrective/preventive actions as necessary & appropriate
  • Create & maintain quality metrics required for management review
  • Develop & maintain procedures & records that demonstrate compliance to the internal aduit program, & the company's QMS
  • Provide training, guidance, & support the company for other QMS related activities
  • Support routine Quality processes such as investigating non-conformances, CAPAs, complaints, other process monitoring activities
  • Ability to independently develop solutions for complex problems
  • Ensure processes are in place that lead to the delivery of quality results & continually assess their effectiveness to drive continual improvement
  • Execute special projects as assigned
  • Report & 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 experience in the Life Sciences Industry, preferably in IVD regulated environment
  • Strong working knowledge of FDA QSR, ISO 13485, ISO 14971 regulations
  • Experience in compliance with quality standards in a regulated Molecular laboratory preferred
  • Certified ISO 13485 lead auditor preferred
  • Effective verbal & written communication skills & ability to share & receive information from all levels of the organization throughout various departments
  • 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
  • Experience with Microsoft Office suite & Internet for business use
Additional Information

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

#GuardantHealth#PatientFirst#LiquidBiopsy#LUNAR#Eclipse#RealWorldEvidence#CDx#CompanionDiagnostics#biojobs#biotechjobs#biotechcareers#biocareers#pharmajobs#oncologyjobs#biotechbay #LI-CM1

Apply To Job
© 2019 GarysGuide      About    Feedback    Press    Terms
Sponsor Gary's (World Famous) Red Tie