Full Job 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 and advanced analytics. The Guardant Health Oncology Platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has launched liquid biopsy-based Guardant360®, Guardant360 CDx and GuardantOMNI® tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.
Perform instrument IQ/OQ/PQ, PMs, and calibrations to ensure that instruments meet Guardant Health’s quality system requirements.
Performance and documentation of internal IQ/OQ/PQs, calibrations, and PM activities per established calibration Standard Operating Procedures and Work Instructions
Proficient in the use of the calibration and maintenance asset management/calibration software (data entry, records maintenance, report generation, and other related required documentation)
Communicate with labs to coordinate installation, and calibration/preventative maintenance events
Evaluate equipment for fitness of use and verification of performance within specified parameters per established calibration procedures
Follow sequence of testing from calibration procedures for instruments and equipment and ensures all tasks are performed in compliance with ISO17025, applicable Standard Operating Procedures, and Work Instructions
Serve as a technical resource on metrology related issues
Provide evaluation of equipment issues by triaging, and recommending the best course of action (i.e., recalibration, PM, or repair) to keep production moving
Perform other duties and responsibilities as assigned
Ensure proper documentation following GDP
Proficient in authoring and executing IQ/OQ/PQ and calibration documentation
Working knowledge of equipment and tools necessary to perform essential job functions
Knowledgeable of metrology with an ability to deal with moderately complex processes and procedures
Excellent communication skills and detail oriented
Experience standardizing processes for scalability and sustainability is a plus
Ability to take part in an on-call rotation with afterhours/weekend response as needed
Willingness to travel up to 20% as needed
BS degree in an engineering or scientific discipline, with a minimum of 3-5 years of related industry experience in science, electrical or related field preferred
Employee may frequently exert up to 20-50 pounds of force to push or lift equipment
This position requires standing/walking/crawling regularly
Employee may be required to lift routine office supplies 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.
All your information will be kept confidential according to EEO guidelines.
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