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QA Documentation Specialist - II
Ref No.: 18-00240
Location: Foster City, California
Position Type:Contract
Title: QA Documentation Specialist II
Location: Foster City, CA
Type: Contract

Responsibilities:
  • Analyzes Change Requests (CRs) for completeness.
  • Collaborates with customers to ensure changes are concise and complete.
  • Assists with the correct and timely implementation of documentation to support filings, projects
  • Advanced knowledge of computer systems which support document control processes
  • Interacts with appropriate departments to establish project priorities and deadlines
  • Revises standard operating procedures (SOPs) and work instructions for continuous improvement of documentation systems.
  • Coordinates the distribution and maintenance for GXP documentation.
  • Provides support to internal and regulatory audits/inspections as required.
  • Performs administration of the Quality Management System in support of GXP documentation.
  • Supports the generation of monthly document control metrics.
  • Participates in the development of training materials.
  • Identifies areas for improvements, and proposes changes to management.
  • Performs advanced word processing tasks including providing support to customers with documentation issues.
Requirements:
  • Demonstrates advanced understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
  • Demonstrates advanced working knowledge of Document Control fundamentals, knowledge of the process, effects, and the relationship between the document change process and products.
  • Demonstrates advanced working knowledge of Quality Systems fundamentals.
  • Demonstrates general working knowledge of Electronic Document Management Systems (EDMS).
  • Demonstrates advanced understanding of computer system administration.
  • Demonstrates good verbal, written, and interpersonal communication skills.
  • Demonstrates advanced knowledge in Microsoft Office applications.
Education & Experience:
  • 6+ years of relevant experience and a High School diploma.
  • 4+ years of relevant experience in the pharmaceutical industry and a BS.