Analyst, QC 1

San Rafael, California | Contract

Post Date: 11/07/2017 Job ID: 3542 Industry: Quality and Regulatory Affairs

Our focus is 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.

Duties:
  • Participates in product/project coordination internally, and with outside laboratories.
  • Manages shipments (inventory, packaging, documentation, and coordination) to partner laboratories.
  • Maintains laboratory supply inventories, and preparation for critical reagents.
  • Manages data trends for critical reagents and reference material.
  • Maintains the laboratory in an inspection-ready state.
  • Provides support for routine laboratory functions/chores for the QC laboratory.
  • Assists in the preparation/revision of routine and non-routine study protocols and reports and qualification documents.
  • Trains other analysts in areas of expertise on basic assays as well as more complex assays that are mastered.
  • Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
  • Interacts with other departments, including but not limited to  Shipping, Regulatory, Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
  •   Performs, under direct or minimal supervision, biochemical/physical/chemical 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.

 

Skills:

  • At least one year in a cGMP/GLP laboratory; quality control experience is p
  • 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.
  • Experience with bioassay and/or HPLC techniques.
  • Good written, verbal, and communication skills.
  • Good documentation skills.
  • Demonstrates the ability to work independently
  • Detail oriented and organized
  • Ability to multitask

Education: B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least 1 year of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.

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