Qa Specialist - Document Management System

Amgen Inc

Technical writing and editing expertise
Dms process optimization and maintenance
Document authoring standards
Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents

Job Summary

  • Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents.
  • Support optimization and maintenance of the DMS process, including updates to the procedure, the system (CDOCS), and associated training materials.
  • Due to the global nature of the role, must be willing to work a shift that overlaps with EU and US time zones long term (ex. coverage of 9 - 12 EST at a minimum within the shift).

Matching Summary

Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents.

Skills & Requirements

Must-have

  • Technical writing and editing expertise
  • DMS process optimization and maintenance
  • Document authoring standards
  • CDOCS support portal maintenance
  • Global time zone overlap

Nice-to-have

  • Exceptional attention to detail
  • Proactive in a fast-paced environment
  • Proficiency in Microsoft Office Suite
  • Solid understanding of SOP/Standards management
  • Knowledge management across Quality operations

Key Requirements

  • Master’s degree and 8 to 10 years experience
  • Bachelor’s degree and 10 to 12 years experience
  • Prior technical writing experience in regulated space
  • Experience in GMP regulations
  • Experience within Biotech/pharmaceutical Research

Work Rights

Not specified

Tailored Resume

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