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
