QA Specialist

Bothell, Washington
Industry: QA Testers
Job Number: JN -062021-65565

PURPOSE AND SCOPE OF POSITION:

  • The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.

Education:

  • Bachelor’s degree or equivalent

Experience Basic Qualifications:

  • Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment
  • Strong communication and customer service skills.
  • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • Must demonstrate the following behaviors consistently: Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Experience interacting with FDA or other regulatory agencies strongly preferred
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)
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