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QA Specialist - Document Management System

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Amgen

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Location:
India , Hyderabad

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Category:
-

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

QA Specialist- Document Management System (DMS) Tech Writing & Operations Support. In this vital role you will be responsible for supporting key strategic initiatives, assigned tasks and/or projects necessary to Amgen’s strategic mission and departmental goals.

Job Responsibility:

  • Support optimization and maintenance of the DMS process, including updates to the procedure, the system (CDOCS), and associated training materials
  • Maintain and enhance DMS document templates and authoring standards to ensure consistency and compliance
  • Lead tech writing tasks in support of process and document simplification efforts
  • Create, update, and deliver training materials for document owners, reviewers, and approvers on good Quality writing per our document hierarchy and document authoring standards
  • Update, optimize, and maintain the CDOCS support portal (SharePoint) – including training links, e-Learnings, Quick Reference Guides, and other related materials
  • Support of Document Management Network – maintenance of meetings, Teams channel, inspection readiness materials, etc.
  • Management of DMS-related suppliers including periodic monitoring and quality agreement management
  • Provide additional operational support for DMS activities as needed

Requirements:

  • Doctorate degree and x years of Quality, R&D, and/or Manufacturing experience
  • Master’s degree and x years of Quality, R&D, and/or Manufacturing experience
  • Bachelor’s degree and x years of Quality, R&D, and/or Manufacturing experience
  • Associate’s degree and x years of Quality, R&D, and/or Manufacturing experience
  • High school diploma / GED and x years of Quality, R&D, and/or Manufacturing experience
  • Prior technical writing experience in a regulated space
  • Superior proficiency in English grammar, syntax, and style

Nice to have:

  • Prior experience in the regulated document management space
  • Experience in developing and delivering training programs or educational materials
  • Ability to effectively communicate complex information to diverse audiences
  • Understanding of global regulatory requirements affecting the Pharma/Biotech sector
  • Excellent project management skills, with the ability to manage multiple initiatives simultaneously

Additional Information:

Job Posted:
January 31, 2026

Work Type:
On-site work
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