Quality Control Analyst I

The Position

The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution.)

The Opportunity:

Please note that this position has swing shift. Availability to work during afternoons and nights is required, as well as to work at least one weekend day.

Responsibilities include sampling and testing of utility systems (Color, Appearance, Odor, TOC, Conductivity, Bioburden, Endotoxin, Particulates and Moisture), facility monitoring (viable monitoring plates and non-viable particulate), data trending and report generation.

Responsibilities:

Other responsibilities include in-process samples and compendial final product testing, chemical and microbiological analysis of cleaning changeover samples, testing of biological indicators and media fill readout. The candidate will share maintenance responsibilities with other laboratory personnel such as reagent preparation, media growth promotion, and cleaning of incubators and biosafety cabinets.

• Sample and test process water samples, compressed gases and perform environmental monitoring. Evaluate water and environmental samples
• Perform of chemical, bio-analytical and 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 particulate analysis
• Perform C of A analysis of bulk raw materials such as nitrogen
• Participate in validation projects (e.g. control and release of biological indicators) and generate trend charts, test reports, etc.
• Perform routine lab maintenance and perform growth promotion on incoming microbiological media for QC and Manufacturing
• Support cleaning and maintenance of basic lab equipment
• Ensure that cGMP compliance is followed
  
  

Who you are:

(Minimum Requirements)

• BS/BA degree, or minimum of 2 years experience in a related industry, or an equivalent combination of education and experience
• Experience in performing chemical and microbiological product testing in a cGMP environment preferred
• Experience working with water system and environmental monitoring a plus
  
  

Work Environment/Physical Demands/Safety Considerations

Work in office and laboratory environment.

• Lift up to 25lbs may be required.
• Ability to work off shifts and/or weekends.
• Ability to sit, stand and move within work space for extended periods.
• May be required to sit at a computer terminal for extended periods.
  
  

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Oregon is $46,000- $65,700 Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.