Quality Control Analyst

3 weeks ago

Novato, United States Compass Consulting Full time

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.


Job Summary:

The Quality Control Analyst is responsible for performing microbiological, biochemical and chemical tests of in-process product, equipment, and manufacturing facilities. The incumbent will be responsible for performing microbiological and analytical testing under cGMP guidelines. Performing a wide variety of tests for microbiological, biochemical, and chemical assays, supporting process validation studies, conducting investigations, analytical method or equipment validation, assay method/procedure development, and reagent preparation.


The position requires knowledge of but is not limited to:

  • HPLC, Enzyme activity, protein by UV spectrophotometry or Bradford/BCA, kinetic chromogenic endotoxin, bio burden determination, Total Organic Carbon, microbial identification, aseptic techniques, microbial challenge studies, microbiological method validation, and other similar analysis methods.
  • Work assignments will encompass activities from routine to complex in nature with the ability to recognize deviations from the accepted or routine practice.
  • The incumbent will be responsible for completing assignments in a timely manner, for assay troubleshooting, data trending, and for follow-up on any testing issues.
  • The incumbent should be able to work independently and prioritize multiple tasks.
  • Good record keeping, organizational, written and verbal communication skills are essential. The incumbent must be willing to work second shift, overtime, weekends and holidays as required.


Responsibilities Include:

  • Perform microbiological/ biochemical/ chemical analyses of in-process product, facility and utility testing under cGMP to meet specified timelines.
  • Assist with the preparation of investigations, technical reports and trend reports.
  • Support method validation, transfer, routine, and non-routine study protocols.
  • Control laboratory inventories.
  • Maintain the laboratory in an inspection ready state.
  • Provide backup support of analytical chemistry/biochemistry assays for Analytical and Raw Materials Groups.
  • Provide on call coverage for Action level conditions to support production testing and quality control laboratory equipment.
  • Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.


Qualifications:

Bachelor Degree, preferably in the Life sciences

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