Quality Control Analyst 8/31/2016

Genomic Health Redwood City, CA

Company
Genomic Health
Job Classification
Full Time
Company Ref #
2016-4718
AJE Ref #
576029102
Location
Redwood City, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
OVERVIEW:

The primary role of this position is to conduct the daily operation of QC inspection and testing of raw materials and in-house manufactured reagents. This includes completing the requisite documentation such as QC worksheets and specification sheets. In addition, the QC analyst II will be responsible for Reagent Quality laboratory activities, such as calibration and maintenance of instrumentation and preparation and qualification of test standards. The QC analyst II will help identify quality issues with reagents and consumables and participate in out-of-specification and failure investigations and implement corrective actions and process improvements. He or she will also help conduct new analytical method and instrument qualification studies.

The position will report to the Associate Director, Reagents Manufacturing and Quality within the Operations organization.

RESPONSIBILITIES:

*

B.S. Degree in biochemistry, analytical chemistry, chemical engineering, or related discipline with 4 - 5 years of relevant experience in industry or CLIA laboratory setting * Perform inspection of incoming raw materials and in-house manufactured reagents.

* Conduct QC testing of materials and reagents using various analytical methods including but not limited to IE-HPLC, UV Spectrophotometry, and Enzyme Activity Assays

* Document results according to SOPs and GHI quality requirements

* Perform QC lab support activities such as buffer preparation, reagent control preparation and testing, and instrumentation maintenance and calibration

* Participate in cross functional team to investigate reagent and consumable quality issue and implement corrective actions

* Identify and troubleshoot equipment issues

* Create analytical method SOPs, instrument procedures, and work instructions

* Partner with Biostatistician to design and conduct new analytical method, software and instrument validation

* Provide support to reagent manufacturing when needed

QUALIFICATIONS:

* QC analyst experience in a regulated environment

* Working knowledge with various analytical techniques including HPLC, pH, Conductivity, and UV Spectrophotometry

* Ability to create and follow SOPs

* Ability to handle multiple tasks concurrently and in a timely fashion

* Ability to work independently with minimal supervision.

* Detail oriented, thorough, and good communication skills

* Proficiency in basic word processing and spreadsheet applications

* Experience in development of analytical methods for oligonucleotide testing is desired

* Chromeleon CDS, SoftMax Pro, JMP software skills are desired

* Hands-on experience in reagent manufacturing a plus

TRAVEL, PHYSICAL/MENTAL 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.