Quality Assurance Specialist

3 weeks ago


Bothell, United States SSi People Full time

Quality Assurance Specialist

Location: Bothell, WA



Major duties and responsibilities:

  • Quality Management System performance metric preparation and reporting. Compile, contextualize, evaluate, and present Quality Systems data and metrics.
  • Investigation & CAPA Review Board Administrator. Compile slides and assemble presentations, schedule logistics, meeting facilitation, and author meeting minutes.
  • QMS Deviation and CAPA phase tracking and due date monitoring.
  • Ensure adherence to deviation and CAPA due dates and extension process.
  • Deviation Trending Program administrator.
  • Perform quarterly analysis and identification of adverse trends. Author quarterly deviation trend report. Work cross-functionally to determine remedial actions to reduce recurrence and implement effective CAPAs.
  • Deviation Trend Review Board logistics, preparation, facilitation, and meeting minutes.
  • Perform routine and ad hoc queries of Quality Management System to support business operations.
  • Other duites as assigned by manager


Education:

  • B.S. in any Science


Experience / Knowledge Desired:

  • A minimum of 3 years of experience in pharmaceutical Quality Assurance, with direct experience in Quality Management Systems. (Veeva experience preferred)
  • Advanced Excel knowledge and proficiency. Pivot table and reporting proficiency.
  • Advance Smartsheet Dashboard Creation
  • Technical report authoring experience. e.g. Deviation Trend Report
  • Must exercise accurate judgment and be able to evaluate information critically and decide upon the appropriate course of action.
  • Must be able to correlate events and determine the action plan required to avoid recurrence.
  • Excellent verbal and written communication skills are essential.
  • Excellent interpersonal skills at every level.
  • Capable of managing priorities and timelines.



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