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QA Documentation Specialist - II
Ref No.: 18-06885
Location: Foster City, California
Job 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.

Knowledge & Skills
 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.

Typical Education & Experience
 6+ years of relevant experience and a High School diploma.
 4+ years of relevant experience in the pharmaceutical industry and a BS.