Guardant 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.
The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and 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 and GuardantOMNI, for advanced stage cancer patients, and is developing programs for recurrence and early detection, called Project LUNAR.
Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
This Senior Quality Specialist (Tissue Genotyping) will support Guardant Health’s quality system requirements, and conformance to regulatory requirements.
This role will focus on leading and providing support to major projects, investigations, training and CAPAs. This role will drive for efficiency in procedures and practices for the Clinical Laboratory and identify opportunities for continual improvement.
- Owns all activities related to the clinical laboratory, including activites related to pre-analytical, analytical and post analytical phases
- Supports clinical laboratory related issues and works closely to determine root cause and potential preventative/corrective actions
- Ensures that training and competency for the clinical laboratory is maintained
- Reviews and approves any laboratory validation life cycle documentation including, protocols and reports
- Performs trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management
- Ensures that the laboratory licenses are maintained
- Represents Quality at cross functional meetings
- Supports 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 and is significantly involved in inspections by regulatory agencies.
- Develops and maintains organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
- Ensures that all policies, procedures, and records are reviewed and approved
- Executes special projects as assigned
- Reports and documents all concern of test quality and/or safety to the Supervisor or Safety Officer, as applicable.
- BS 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.)
- Working knowledge of GCP, ISO 15189 preferred
- Experience with utilizing a Laboratory Information Management System (LIMS) is preferred
- Experience with Microsoft Office suite
- Effective verbal and written communication skills and ability to share and receive information from all levels of the organization
- Ability to work effectively in a team environment
- Ability to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
- Ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
- Proven attention to detail
- 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
Your information will be kept confidential according to EEO guidelines.
Employee may be required to lift routine office supplies up to 20 lbs 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.
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Please visit our career page at: http://www.guardanthealth.com/jobs/