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.
This Sr. Quality Specialist, Clinical Laboratory will support Guardant Health's quality system requirements, & conformance to regulatory requirements. This role will be focused on leading & providing support to major projects, investigations, training & CAPAs. This role will drive for efficiency in procedures & practices for the Clinical Laboratory & identify opportunities for continual improvement.
- Responsible for owning all activities related to the clinical laboratory, including activites related to pre-analytical, analytical & post analytical phases
- Support clinical laboratory related issues & work closely to determining root cause & potential preventative/corrective actions
- Ensure that training & competency for the clinical laboratory is maintained
- Review & approve any laboratory validation life cycle documentation including, protocols & reports
- Perform trending analysis (Quality Metrics) on a routine basis by identifying, generating & publishing metrics & reports related to the Quality System performance & reporting anomalies to management
- Ensure that the laboratory licenses are maintained
- Represent Quality at cross functional meetings
- Support other routine Quality processes such as document control, employee training, investigations, equipment qualifications, internal audits, as required
- Serve as a Subject Matter Expert for Laboratory Operations internal or external matters. Participates in inspection readiness activities & is significantly involved in inspections by regulatory agencies.
- Develop & maintain organized records that demonstrate compliance to all company processes, regulations, & the company's QMS
- Ensure that all policies, procedures, & records are reviewed & approved
- Execute special projects as assigned
- Report & document all concern 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 a CLIA/CAP laboratory
- Experience in compliance with quality standards in a regulated Molecular laboratory (e.g. CLIA, CAP, NYSDOH, etc.)
- Effective verbal & written communication skills & ability to share & receive information from all levels of the organization
- 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
- 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
- Working knowledge of GCP, ISO 15189 preferred
- Experience with utilizing a Laboratory Information Management System is preferred
All your information will be kept confidential according to EEO guidelines.
Employee may be required to lift routine office supplies up to 20 lbs & 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.
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