Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

The Tissue Associate II provides a vital link between internal customer service, clinical operations, and Histology in support of Tissue Genotyping. The Tissue Associate II is responsible for receiving, unpacking, processing and recording samples sent for laboratory testing under the supervision of the Supervisor/Manager.  The Tissue Associate II  works with the Tissue Associate to coordinate tasks, divide workload and manage projects.  He/she has demonstrated a good understanding of the laboratory workflow. 

In addition to the primary role of sample accessioning, there may be a need to provide back-up support (non-testing) to the Analytical and/or Post-Analytical team, on an as needed basis.  It is imperative that the Tissue Associate II have demonstrated the ability to work independently, but also function effectively as a member of the Guardant Health team. The nature of the work requires keeping meticulous and organized records, excellent attention to detail, effective written and verbal communication skills, the ability to multi-task and be flexible with tasks and schedules, and the ability to work independently in a team environment.

Essential Duties and Responsibilities:

Support the Clinical Lab personnel in performing task such as sample intake, verification, accessioning, returning of clinical specimen to source pathology laboratories and conducting transfers to internal departments as well as external laboratories.Responsible for receiving, unpacking and processing all incoming clinical and non-clinical specimens.Responsible for entering and verifying data in the Laboratory Information Management System (LIMS) database.Understand, execute, and maintain the Tissue (Pharma) RUO/IST and IUO workflows.Prepare clinical samples for in-house testing and/or the use of an external reference laboratory.Apply unique labels to Formalin Fixed Paraffin Embedded (FFPE) blocks and slides during sample accessioning to maintain genealogy during downstream testing and report generation. Manage sample storage inventory of FFPE blocks, unstained slides, and stained slidesResolve and document discrepancies, incomplete, and/or unacceptable specimens.Review and analyze pathology reports from source pathology laboratory that corresponds with the specimen received and verify Diagnosis correlation.Verify aspects of incoming samples and assess acceptability of sample for testing.Resolve and document incomplete or unacceptable specimens.Mediate transfers to and from an external reference laboratory while maintaining chain of custody and GDP requirements.Organize clinical specimens and manage sample storage inventory and arrange sample transfers to various departments.Prepare, package, and return patient specimens to corresponding source pathology laboratory within allocated time frame, once testing is complete.Coordinate with Guardant Health facilities to ensure specimens are returned accordingly.Input and update Tissue Trackers to assist with day-to-day workflow.Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.Initiate, investigate, and complete Nonconformance Reports (NCRs) within 30 days/Corrective and Preventative Action (CAPAs)Follow Good Lab Practice (GLP) with the organization and upkeep of the laboratory, lab benches and other laboratory suppliesOperate, maintain, and troubleshoot equipment maintenance and maintain equipment logs and records according to the laboratory’s SOPs.Verify, monitor, and record temperatures of equipment and storage units by applying quality control procedures and initiate a service request when necessary.Carry out and maintain sufficient inventory of laboratory stock for daily operations.Work closely with the Leads of the Analytical, Post Analytical, Client Services, Reporting and Tech Dev Teams to provide consistent and ongoing support to the entire service department.Support the administrative functions of the lab as required.Perform other miscellaneous duties as assigned and assist others as time allows.Assist in the update and development of SOPs pertaining to Biospecimen Management workflows.Assist with training of new laboratory personnel and training of new procedures with existing personnel.Provide support, guidance, and constructive feedback to Tissue Associate.The Tissue Associate II may oversee Tissue Associates in the absence of Supervisor and/or designee.Assist with internal audits and inspection preparation, as needed.Identify process improvement opportunities and report to laboratory management.Report all concerns of test quality and/or safety to the Supervisor or Safety Officer.

QualificationsMinimum of Associate of II Arts or equivalent experience requiredBachelor of Arts or Science in Biomedical Laboratory Science, Clinical Science or related field preferredA minimum of 1 year of related experiences in a high complexity laboratory requiredA minimum of 1 year of sample accessioning experience or equivalent data entry requiredPipetting or other equivalent laboratory experience requiredPrevious experience with Excel, Smartsheet, and Salesforce applications preferredPrevious experience working with LIMS or other data management systems preferredDemonstrate a high level of competency when assisting in the pre-analytical sample processing stepsAbility to proactively communicate consistently, clearly, and honestly Strong computing skillsStrong communicator with ability to maintain open communication with internal employees, managers and customers, as neededStrong analysis and problem solving skillsAbility to prepare and maintain records and logsAbility to integrate and apply feedback in a professional manner Ability to prioritize tasks with a high emphasis on qualityAbility to analyze and solve basic issues Ability to work independently and as part of a team

Work Environment:

Hours and 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 and instruments with moving parts, heating or freezing elements, and high-speed centrifugation;Repetitive manual pipetting may be necessary; andSome lifting (up to 25 pounds) may be necessary

Additional Information

For positions based in Long Island City, NY, the hourly range for this full-time position is $26 to $36. The range does not include benefits and, if applicable, overtime, bonus, commission, or equity.

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the recruiting team will provide details specific to the factors above.

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 committed to providing reasonable accommodations in our hiring processes for candidates with disabilities, long-term conditions, mental health conditions, or sincerely held religious beliefs. If you need support, please reach out to [email protected]

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.

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.

Please visit our career page at: http://www.guardanthealth.com/jobs/

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