Quality Control Analyst

Organization
Genomic Health
Job Location
Redwood City, CA 94063
Job Description

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.

 

Requirements
  • 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
  • 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

 

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About Our Organization

Genomic Health

  

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