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Senior Clinical Laboratory Scientist I - QC

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POST DATE 9/1/2016
END DATE 10/19/2016

Genomic Health Redwood City, CA

Company
Genomic Health
Job Classification
Full Time
Company Ref #
2016-4716
AJE Ref #
576051051
Location
Redwood City, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
OVERVIEW:

The Senior CLS I - QC is an integral member of the Reagent Manufacturing and Quality team, with primary responsibility of ensuring the consistent quality of reagents and consumables used by Genomic Health s Clinical Laboratory. He or she is responsible for performing high complexity laboratory testing and contributing to the creation and implementation of required test methods, stability data, associated study protocols, reports and standard operating procedures to ensure quality issues with reagent or consumable lots are discovered and addressed prior to their use in our Clinical Laboratory. The Senior CLS I - QC is involved in preparing and qualifying controls for instruments qualification and assay performance monitoring. He or she will also participate in investigation of reagent quality issues, help drive continual improvement in efficiency of clinical laboratory and QC workflows, develop new and improve existing QC methods, and train manufacturing or laboratory staff in new processes.

The high complexity nature of the work requires 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 both independently and in a team environment.

RESPONSIBILITIES:

* Perform, review, and document reagent quality testing according to the laboratory s standard operating procedures.

* Identify and help troubleshoot high complexity issues that adversely affect reagent quality test results.

* Manufacture and qualify process and instrument controls used by the Clinical Lab.

* Participate in cross-functional teams to test and validate new reagents and consumables and conduct stability studies of reagents.

* Participate in effort to develop, validate, and implement quality control test methods for reagents and plastic consumables to reduce variability of genomic assays used for commercial patient sample testing and in clinical development studies.

* 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.

* Assist in investigation and resolution of reagent / consumable-related issues with our laboratory processes.

* Collaborate with colleagues in Quality, Supply Chain Management, Biostatistics, Process Engineering, R&D, and other functions to address and prevent supplier quality issues.

QUALIFICATIONS:

* Must possess a valid California CLS license or equivalent, such as CGMBS

* Clinical laboratory work experience within the last five years.

* Minimum of 7 years of clinical laboratory experience as a CLS, CGMBS or equivalent, with at least 5 years in a high complexity molecular laboratory.

* Possess intermediate to advanced working knowledge of local, state and federal laboratory regulations.

* Hands-on experience with automated equipment, such as Tecan and Hamilton robotic systems.

* Strong computer skills, including but not limited to Microsoft Office and LIMS.

* Strong molecular biology technical skills such as nucleic acid isolation, RNA/DNA quantification, PCR and RT-PCR, and DNA sequencing.

* Ability to proactively communicate consistently, clearly and honestly and to maintain open communication with internal employees, managers and customers as needed.

* Ability to effectively communicate technical information to technical and non-technical audiences.

* Able to manage daily test processing needs along with project needs in a high quality, efficient and effective manner.

* Ability to work as part of a team.

* Ability to perform repetitive tasks with sustained high quality.

* Experience with Next Generation Sequencing techniques desirable.

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:

* Travel Requirements: No Travel

* Standing or sitting for long periods of time may be necessary

* Some lifting (greater than 25 pounds) may be necessary

* May be exposed to hazardous materials, tissue specimens and instruments with moving parts, lasers, heating and freezing elements, and high speed centrifugation

* Repetitive manual pipetting is necessary

COMPANY PROFILE:

Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer, one of the greatest issues in healthcare today. With its Oncotype IQ Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit,www.GenomicHealth.comand follow the company on Twitter: @GenomicHealth,Facebook,YouTubeandLinkedIn.

Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential. We value our employees and consider them an integral part of our company s growth and success. We maintain competitive total rewards programs designed to satisfy our employees work life and personal life needs.

To learn more about careers at Genomic Health visit: http://www.genomichealth.com/join_our_team

All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.