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Quality Control Analyst

Marin Metro Area, California

Post Date: 06/21/2017 Job ID: JN -062017-19361 Industry: QC - Scientific
DUTIES:
  • 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
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.
  • Proficient at physiochemical, enzymatic, and/or cell based assays

EDUCATION:
  • Bachelor's Degree in science (major in biology-biochemistry-chemistry) with 5 years of experience

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