Job Description

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