QC Associate

3 months ago


Fremont, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionFremont, CAContract Duration: 12-24 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a QC Associate III in the Fremont, CA area.
  • Performs sampling/testing/inspection of raw materials, conducts lab investigations, and reports aberrant results to management.
  • Includes, not limited to: Pulling and aliquoting raw material samples and distributing to the appropriate laboratories.
  • Prepares paperwork, ships samples, and follows-up with appropriate testing laboratories.
  • AQL inspection (e.g., visual, dimension, etc.)
  • On call/weekend/swing shift coverage for urgent samples.
  • Data entry and reviews QC documentation (e.g., test results, data packets, etc.)
  • Generates, reviews and/or maintains records or documents in a detailed and consistent manner (e.g., sample summary form, test records, etc.).
  • Reconciles samples.
  • Perform required reviews of appropriate forms (e.g., test records) and logbooks.
  • Performs an Owner role for Change Controls and Deviations
  • Prepares and reviews-trend reports, generate metrics and other reports as needed.
  • Maintains raw material data. Revises SOPs, training doc, etc.
  • Ensures equipment calibration and preventive maintenance are up to date.
  • Performs an Owner role for Change Controls and Deviations.

Experience:

  • Bachelors' Degree in a Scientific Discipline. In depth experience in a laboratory environment Five (5) years cGMP or appropriate experience required.
  • Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards desired.
  • Strong technical writing required.
  • Knowledge of CFR, USP, and ICH required.
  • Knowledge of SAP Track wise and LIMS desired.
  • Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems.
  • Demonstrated problem-detection and problem-resolution skills required
  • Lifting, carrying, pushing or pulling up to 50 pounds occasionally Frequent periods of sitting, walking, and standing
  • Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat
  • Occasional low-level work, fine finger dexterity/ including grasping or pinching required
  • Occasional use of personal protective equipment
  • Required Skills: GMP, USP, EUROPEAN PHARMACOPIA, MS OFFICE, LIMS,
  • Additional Skills: GMP ISO, ICH,


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