QA Specialist - Document Management System

QA Specialist- Document Management System (DMS) Tech Writing & Operations Support

What you will do

Let’s do this. Let’s change the world. 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 including the following activities:

• 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

Basic Qualifications:

• Doctorate degree and x years of Quality, R&D, and/or Manufacturing experience Or
• Master’s degree and x years of Quality, R&D, and/or Manufacturing experience Or
• Bachelor’s degree and x years of Quality, R&D, and/or Manufacturing experience Or
• Associate’s degree and x years of Quality, R&D, and/or Manufacturing experience Or
• 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

Preferred Qualifications:

• 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