QC Analyst

San Rafael, CA 94901 | Contract

Post Date: 07/23/2018 Job ID: 4520 Industry: Quality

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.


  • The Contract Analyst under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples.
  • Contract Analysts work independently on assays that he/she has mastered.
  • They must be able to work on projects with little supervision, write and execute method validation and special studies, and have some oversight of a product line.
  • Responsibilities:
  • Perform, under moderate supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. 
  • Work independently on assays that he/she has mastered.
  • Evaluate data against defined criteria/specifications.
  • Maintain laboratory supply inventories.
  • Maintain the laboratory in an inspection-ready state.
  • Provide support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory.
  • Develop and maintain proficiency in a broad range of test methods.
  • Assist in the revision of written procedures as assigned.
  • Assist in the preparation of routine and non-routine study protocols and reports. 
  • Train other analysts in areas of expertise.Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory.



  • At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
  • Ability to follow written instructions and to perform tasks with direct or minimal supervision.
  • Familiarity with use of a computer: e.g.
  • Proficient in Windows, Microsoft Word, Excel,Good written, verbal, and communication skills.
  • Strong documentation skills.



  • Bachelor's Degree in science (major in biology-biochemistry-chemistry).
  • 0-2 years of experience.
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