Clinical Laboratory Scientist, Reagent QC (Mon-Fri 7am-3:30pm)
- 505 Penobscot Dr, Redwood City, CA 94063, USA
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.
This role will play an integral part in performing Quality Control (QC) test methods and specifications for purchased and in-house manufactured reagents and consumables. The high complexity nature of the work demands openness to learning about reagent QC testing, analytical methods and technology, and regulatory requirements. In this role, you will also contribute to the development of new products, new processes, and 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 and implement quality testing methods, stability data, and standard operating procedures to ensure that any quality issues with reagent or consumable lots are discovered and addressed prior to their use in our Clinical Laboratory. You will cooperate with Quality, Supply Chain, Clinical Laboratory personnel, Technology Development, and other teams in investigation of reagent quality issues, help drive continual improvement in efficiency and effectiveness of QC methods. You should also demonstrate strong verbal and written communication skills, great attention to detail, ability to multi-task, be flexible with tasks and schedules, and have experience working both independently and in a team environment.
- Work in compliance with CAP, CLIA, GCLP and GMP
- Demonstrate proficiency, competency and understanding of fundamental principles of clinical laboratory procedures with minimal amount of supervision
- Perform analytical and functional QC testing utilizing laboratory’s standard operating procedures and batch records for release of materials to production inventory
- Adhere to the laboratory's quality control program, and be responsible for documenting all QC activities, instrument, reagent checks and procedural calibrations and maintenance performed
- Ensure consistent compliance with applicable federal, state, and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities
- Perform laboratory tests, procedures and analyses on patient specimens per laboratory’s standard operating procedures based on operational demands
- Review, interpret and report patient results in LIMS, as time allows
- Identify problems that may adversely affect test performance or reporting of test results and assure all remedial actions are taken to correct and address the problems
- Communicate intra-departmentally and with other departments to solve technical issues
- Participate in cross-functional team efforts to develop, validate, and implement quality control test methods for new reagents used for commercial patient sample testing
- Draft or revise procedures, documents, and forms associated with reagent quality testing, as needed
- Collaborate closely with colleagues in Quality, Supply Chain Management, Process Engineering, Technology Development, Bioinformatics, and other functions to address and prevent supplier quality issues
- Utilize job knowledge, judgement, and 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 experience in a CLIA, CAP accredited laboratory preferred
- Candidate must be a team player who is self-driven, motivated, organized, analytical, detailed, and flexible in a fast-paced environment
- Experience with transfer and scale up of new products and processes to QC
- Strong communicator with ability to maintain open communication and collaboration with team members, management, and other departments
- Ability to prioritize and adapt to changing environments while maintaining a high standard on quality
- Previous experience in molecular based laboratory desirable
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.
Please visit our career page at: http://www.guardanthealth.com/jobs/
To learn more about the information collected when you apply for a position at Guardant Health, Inc. and how it is used, please review our Privacy Notice for Job Applicants.