About this role
Career Category
QualityJob 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
Other facts
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
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What you'll do
- The QA Specialist will support the optimization and maintenance of the Document Management System (DMS) process, including updates to procedures and training materials. They will also lead technical writing tasks and manage DMS-related suppliers.
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