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Quality Control Analyst

Marin Metro Area, CA

Post Date: 07/26/2017 Job ID: JN -072017-19635 Industry: Molecular Biology - Scientific
RESPONSIBILITIES:
  • Perform, under minimal 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 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 method validations, protocol, and report writing.
  • Familiarity with cGMP, 21CFR, USP, EP, and ICH regulatory guidance

SKILLS:
  • 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.
  • MUST HAVE experience in at least one of the following techniques for peptide or protein products:
    • ELISA
    • capillary electrophoresis
    • HPLC- RP
    • SEC
    • ion exchange
    • peptide map

EDUCATION:
  • Analyst II Bachelor s Degree in science (major in biology-biochemistry-chemistry) with at least 2-3 years
  • Senior Analyst Bachelor s Degree in science (major in biology-biochemistry-chemistry) with at least 5-6 years

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