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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