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QC Analyst - ELISA, qPCR

Marin Metro Area, California

Post Date: 08/01/2017 Job ID: JN -082017-19674 Industry: Molecular Biology - Scientific
  • Performs, under direct or minimal supervision qPCR, ELISA and other molecular biology analyses of test samples under cGMP to meet specified timelines.
  • Works independently on assays that he/she has mastered and under direct or minimal supervision for those assays that are more complex.
  • Evaluates data against defined criteria/specifications.
  • Maintains laboratory supply inventories.
  • Maintains mammalian and insect cell lines.
  • Provides support for routine laboratory functions/chores for the QC laboratory.
  • Develops and maintains proficiency in a broad range of trained test methods, mainly qPCR and ELISA. Potentially including: aseptic cell culture technique and gel electrophoresis.
  • Assists in the revision of written procedures as assigned.
  • Trains other analysts in mastered techniques.
  • Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
  • Interacts with other departments, including but not limited to Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
  • Required: At least two years performing molecular biology techniques. Proficient it:
    • Proficient in good pipetting techniques
    • handling micro volumes
    • Working with high throughput assay formats (96-well and above).
  • At least two years 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, LIMS.
  • Viral/gene therapy work experience is a plus.
  • Good written, verbal, and communication skills.
  • Good documentation skills.
  • Demonstrates the ability to work independently.
  • B.S./B.A. in a science major (biology/biochemistry/chemistry) with at least 2-3 years of qPCR, ELISA, and any other relevant laboratory experience.

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