QA Specialist - Document Management System
AmgenHyderabad, Telangana, India
Posted February 5, 2026
Full Time
About the Company
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. For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Job Description
The QA Specialist - Document Management System will provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents and maintain and enhance DMS document templates and authoring standards to ensure consistency and compliance.
Requirements
- Master’s degree and 8 to 10years in Pharmaceutical and/ or Biotechnology Quality, R&D, and/or Manufacturing experience
- Bachelor’s degree and 10 to 12 years of in Pharmaceutical and/ or Biotechnology Quality, R&D, and/or Manufacturing experience
- Prior technical writing experience in a regulated space
- Exceptional attention to detail and accuracy in all deliverables.
- Ability to work independently and proactively in a fast-paced environment.
- Proficiency in Microsoft Office Suite & Collaboration tools.
- Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse Quality operations environment.
- Complex document management in the Quality with experience in GMP regulations.
- Effective communication, critical thinking and problem-solving
- Experience within Biotech/pharmaceutical Research, including the application of Global Regulations.
- Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes.
- Independent and team work capabilities
- Operational and compliance-critical administrative support
