Quality Control Associate, Bioassay

Hillsboro, Oregon
United States

Job ID: 2566515023

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The Position

QC Associate

Who We Are

Genentech is a member of the Roche Group and hasbeen at the forefront of the biotechnology industry for more than 40 years,using human genetic information to develop novel medicines for serious andlife-threatening diseases. Genentech has multiple therapies on the market forcancer & other serious illnesses. Please take this opportunity to learnabout Genentech where we believe that our employees are our most importantasset & are dedicated to remaining a great place to work.


Summary

QC Associate’s primary responsibilities includesampling and testing of utility systems (Color, Appearance, Odor, TOC,Conductivity, Bioburden, Endotoxin, Particulates and Moisture), facilitymonitoring (viable monitoring plates and non-viable particulate), in-processand compendial final product testing, and chemical and microbiological analysisof cleaning changeover samples.  QCAssociates share maintenance responsibilities with other laboratory personnelsuch as reagent preparation, media growth promotion, and cleaning of incubatorsand biosafety cabinets. QC Associates also assist the QC Analytical Science andTechnology (ASAT) team with equipment qualification and method transferexecution.

 

The QC Operations teamsupports across a 7-day operation (days and swings) to perform batch release,process and facility support testing to meet the needs of the HillsboroTechnical Operations production.  

 
Responsibilities:
  • Follow proper safety precautions andlaboratory technique in the use of reagents and other chemical compounds,including but not limited to acetonitrile, chlorine, acids and bases, biologictoxins, microorganisms and potent compounds.
  • Review, evaluate and approve testdata against established criteria.
  • Sample and test process watersamples, compressed gases and perform environmental monitoring. Evaluate waterand environmental samples.
  • Perform of chemical, bio-analyticaland microbiological analysis of in-process samples and final products,including but not limited to: Spectrophotometric Scan, pH, bacterial endotoxin,HPLC, GC, bioburden, final product sterility test, and USP particulateanalysis.
  • Participate in validation projects(e.g. control and release of biological indicators) and generate trend charts,test reports, etc.
  • Perform routine lab maintenance andperform growth promotion on incoming microbiological media for QC and Manufacturing
  • Support trouble shooting, cleaningand maintenance of basic lab equipment.
  • Support on-going maintenance of theQC retain file samples program.
  • Review and validate test results.
  • testing of biological indicatorsand media fill readout
 


Who You Are

Who you are


In hiring new employees, we look for people whoare also inspired by our mission and who would fit in well with thecollaborative, rigorous and entrepreneurial spirit of the company culture.Because we know that employees are critical to our success in bringing novelmedicines to patients, we are dedicated to remaining a great place to work andto providing employees with programs, services and benefits that allow them tobring the best to the business and to their personal lives.

 
Requirements:

Education,Experience, Knowledge, and Skills:

  • BA/BSdegree preferably in Life Science and three (3) years relevant experience inthe bio/pharmaceutical industry, or an equivalent combination of education andexperience.
  • Experience in performing microbiologicalproduct testing in a cGMP environment
  • Experience in performing ELISA andcell based assays in a cGMP environment
  • Solidunderstanding of cGMPs or equivalent regulations
  • Abilityto communicate clearly and professionally in writing and verbally
  • Abilityto work off-shift and weekends as required
  • Ensurethat cGMP compliance is followed

WorkEnvironment/Physical Demands/Safety Considerations:

  • Work in office and laboratoryenvironment
  • Lift up to 25lbs may be required
  • Ability to sit, stand and move withinwork space for extended periods
  • May be required to sit at a computerterminal for extended periods

Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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