Guardant Healthis 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 leverages capabilities to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs across all stages of the cancer care continuum.Guardant Healthhas launched liquid biopsy-based Guardant360 & GuardantOMNI tests for advanced stage cancer patients & LUNAR assay for research use & for use in prospective clinical trials. In parallel,Guardant Healthis actively exploring the performance of the LUNAR assay in initial studies related to screening & early detection in asymptomatic individuals.
This role will play an integral part in performing Quality Control (QC) test methods & specifications for purchased & in-house manufactured reagents & consumables. The high complexity nature of the work demands openness to learning about reagent QC testing, analytical methods & technology, & regulatory requirements. In this role, you will also contribute to the development of new products, new processes, & in ensuring the consistent quality of materials used in commercial patient sample testing within our Clinical Laboratory. You will participate in group efforts to create & implement quality testing methods, stability data, & standard operating procedures to ensure that any quality issues with reagent or consumable lots are discovered & addressed prior to their use in our Clinical Laboratory. You will cooperate with Quality, Supply Chain, Clinical Laboratory personnel, Technology Development, & other teams in investigation of reagent quality issues, help drive continual improvement in efficiency & effectiveness of QC methods. You should also demonstrate strong verbal & written communication skills, great attention to detail, ability to multi-task, be flexible with tasks & schedules, & have experience working both independently & in a team environment.
Essential Duties & Responsibilities:
Under the direct & constant supervision by Reagent QC Manager:
- Work in compliance with cGLPs & cGMPs
- Demonstrate proficiency, competency & understanding of fundamental principles of clinical laboratory procedures with minimal amount of supervision
- Perform analytical & functional QC testing utilizing laboratory's standard operating procedures & batch records for release of materials to production inventory
- Adhere to the laboratory's quality control program, & be responsible for documenting all QC activities, instrument, reagent checks & procedural calibrations & maintenance performed
- Ensure consistent compliance with applicable federal, state, & local regulations & quality-related best practices in development, validation, use, & documentation of analytical & functional test methods for reagent lot qualification, stability studies, & related activities
- Perform laboratory tests, procedures & analyses on patient specimens per laboratory's standard operating procedures based on operational workflow
- Review, interpret & report patient results in LIMS, as time allows
- Identify problems that may adversely affect test performance or reporting of test results & assure all remedial actions are taken to correct & address the problems
- Communicate intra-departmentally & with other departments to solve technical issues
- Participate in cross-functional team efforts to develop, validate, & implement quality control test methods for new reagents used for commercial patient sample testing & in clinical development studies
- Draft or revise procedures, documents, & forms associated with reagent quality testing, as needed
- Collaborate closely with colleagues in Quality, Supply Chain Management, Process Engineering, TechDev, & other functions to address & prevent supplier quality issues
- Utilize job knowledge, judgement, & problem-solving skills to ensure quality
- Current California Clinical Laboratory Scientist (CLS) or Clinical Genetic Molecular Biology Scientist (CGMBS) license
- Bachelor's degree in a molecular Biology, Biochemistry, Chemistry, or an associated relevant field
- 2 years of experience in a CLIA, CAP accredited laboratory preferred
- Candidate must be a team player who is self-driven, motivated, organized, analytical, detailed, & flexible in a fast-paced environment
- Experience with transfer & scale up of new products & processes to QC
- Strong communicator with ability to maintain open communication & collaboration with team members, management, & other departments
- Ability to prioritize & adapt to changing environments while maintaining a high standard on quality
- Previous experience in molecular based laboratory desirable.
This opening is a Swing Shift, Monday - Friday 11:00am - 7:30pm & occasional weekends may be required.
- Hours & days may vary depending on operational needs;
- Standing or sitting for long periods of time may be necessary;
- May be exposed to hazardous materials, blood specimens & instruments with moving parts, heating or freezing elements, & high-speed centrifugation;
- Repetitive manual pipetting may be necessary; and
- Some lifting (up to 25 pounds) may be necessary.
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.
All your information will be kept confidential according to EEO guidelines.
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