Quality Assurance

  • location: Novato, CA
  • type: Contract
  • salary: $20.77 - $26.78 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/296425

Analyst, QC I

Responsibilities

  • 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.
  • Evaluates data against defined criteria/specifications.
  • Maintains laboratory supply inventories.
  • Maintains the laboratory in an inspection-ready state.
  • Provides support for routine laboratory functions/chores for the QC laboratory.
  • Participates in product/project coordination.
  • Assists in the revision of written procedures as assigned.
  • Assists in the preparation 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 Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
  • Manages data trends for critical reagents and reference material.

Education / Qualifications

  • B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least 2-3 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.
  • 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, 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

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296425

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