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QA Documentation Specialist - I
Ref No.: 18-00277
Location: Foster City, California
Position Type:Contract
Title: QA Documentation Specialist I
Location: Foster City, CA
Type: Contract

Responsibilities:
  • Collaborates with customers to ensure the correct and timely implementation customer requests and document processing.
  • Supports the distribution and maintenance of GXP documentation.
  • Scans, verifies and archives documentation as needed
  • Recommends process improvements and proposes changes.
  • Provides support with internal and regulatory audits/inspections as required.
  • Understand and use document templates.
  • Supports the maintenance of monthly document control metrics.
  • Performs general word processing tasks and support. Checks format and conformance to document templates, verifies own work.
  • Provides additional support and assistance on tasks and projects as directed by management.
  • Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues.
Experience:
  • Demonstrates knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
  • Demonstrates general knowledge of the processes and impact of document control, and the relationship between the document change process and products.
  • Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
  • Demonstrates working knowledge of Electronic Document Management Systems (EDMS).
  • Keeps abreast of the basic requirements for compliance in own work area.
  • Demonstrates a high degree of attention to detail
  • Demonstrates problem solving skills.
  • Demonstrates proficiency in Microsoft Office applications Oracle environment.
  • Demonstrates strong verbal, written, and interpersonal communication skills.
Education:
  • 5+ years of relevant experience in the pharmaceutical industry and a High School diploma.
  • 3+ years of experience and AA degree.