Associate Quality Systems Specialist

3 weeks ago

Rocklin, United States The Fountain Group Full time

Currently seeking a Associate Quality Systems Specialist for a prominent client of ours. This position is located in Rocklin, CA. Details for the position are as follows:

Job Description:

  • Shift: Monday-Friday 1st shift.
  • Pay: $26-$27/hr depending on experience.
  • This is a temporary assignment that is slated for 1 year with possibility for extension or conversion based on performance and budget.
  • Position is responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual.
  • Position is also responsible for performing project review and audit of Device History Files (DHF's) and technical files including:
    • Stability protocols and reports
    • Summary of Safety and Performance reports
    • Risk Management plans, reports, FMEAs
    • Post-Market Surveillance plans and reports
    • Performance evaluation plans and reports including scientific, clinical, and analytical documents.
    • Product composition reports
    • Sensitivity and specificity/Repeatability and reproducibility reports
    • Specification reports
    • General Safety and Performance Requirement reports
Qualifications:
  • High school diploma or a bachelor's degree with 1 year of experience reviewing documentation within a GMP environment.
  • Medical device or pharmaceutical experience preferred.

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