QA Specialist – Document Management System (DMS)
Job ID: R-233331
Function: Quality Assurance
Location: Hyderabad, Telangana, India
Work Mode: On-site
Employment Type: Full-Time
Experience Required: Typically 3–8 years (based on education level)
Posted Date: 28 January 2026
Job Overview
Amgen is seeking a QA Specialist – Document Management System (DMS) to support quality-driven documentation, technical writing, and operational excellence within its regulated environment. This role is critical to maintaining and optimizing the Document Management System (CDOCS), ensuring compliance with global quality standards, and enabling inspection readiness across the organization.
The position offers hands-on involvement in document lifecycle management, quality writing standards, training delivery, and continuous improvement initiatives within a global biopharmaceutical quality framework.
About Amgen
Amgen is a leading biotechnology company committed to discovering, developing, and delivering innovative medicines for patients with serious illnesses. With a strong culture of quality, compliance, and scientific excellence, Amgen empowers professionals to contribute meaningfully to global healthcare while advancing their careers in a regulated, high-impact environment.
Key Responsibilities
Support the optimization, maintenance, and continuous improvement of the Document Management System (DMS), including procedures, CDOCS system updates, and related training materials.
Maintain and enhance DMS document templates and authoring standards to ensure consistency, clarity, and regulatory compliance.
Lead technical writing activities focused on document simplification, standardization, and quality improvement.
Develop, update, and deliver training materials for document owners, reviewers, and approvers on quality writing principles, document hierarchy, and authoring standards.
Update and manage the CDOCS support portal (SharePoint), including e-learnings, quick reference guides, training links, and supporting resources.
Provide operational support to the Document Management Network, including meeting coordination, Teams channel maintenance, and inspection readiness documentation.
Manage DMS-related suppliers, including performance monitoring and quality agreement oversight.
Support additional DMS operations and quality initiatives as required by business needs.
Qualifications & Experience
Education & Experience (experience varies by qualification):
Doctorate with relevant Quality, R&D, or Manufacturing experience
Master’s degree with relevant Quality, R&D, or Manufacturing experience
Bachelor’s degree with relevant Quality, R&D, or Manufacturing experience
Associate degree or Diploma with relevant Quality, R&D, or Manufacturing experience
High school diploma or GED with substantial relevant experience
Typical experience range: 3–8 years in a regulated Quality, R&D, Manufacturing, or Document Management environment.
Required Skills:
Prior technical writing experience in a regulated industry (pharma, biotech, medical devices, or life sciences).
Strong command of English grammar, syntax, and professional writing standards.
Hands-on experience supporting document lifecycle management and quality documentation processes.
Preferred Qualifications
Experience working within a regulated document management system environment.
Background in training development and delivery for quality or compliance topics.
Ability to communicate complex technical and regulatory concepts to diverse stakeholders.
Understanding of global regulatory requirements impacting the pharmaceutical and biotechnology sectors.
Strong project management and organizational skills, with the ability to manage multiple initiatives simultaneously.
Why Join Amgen
At Amgen, quality is foundational to everything we do. You will work in a collaborative, compliance-focused environment that values continuous learning, operational excellence, and meaningful contributions to patient safety and product quality.
SEO & Search Keywords
QA Specialist DMS jobs in Hyderabad, Document Management System QA roles India, Amgen Quality careers, Technical Writer Quality Assurance pharma, CDOCS DMS jobs, Quality documentation specialist India, Pharma QA jobs Hyderabad.
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