R&D Quality Documentation Coordinator

Amgen; United States; Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Retirement plan

Group medical, dental & vision

Life & disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Generous time-off plans

Flexible work models

Job summary

Amgen is seeking an Associate Quality Compliance professional to support the R&D Quality Management System. You will manage controlled documents like SOPs and work instructions, ensuring development, maintenance, and retirement align with global standards and GCP regulations.

You will collaborate across functions to drive approvals, perform quality checks, and help maintain inspection readiness. A strong emphasis on detail, communication, and workflow management is required.

Qualifications

• Basic qualifications include a high school diploma or GED with related experience, an Associate’s or Bachelor’s degree with experience.
• Preferred qualifications emphasize attention to detail, strong writing and communication, and ability to manage document workflows.

Responsibilities

• Execute and track document workflows in the controlled document management system (CDOCS).
• Perform impact analysis for controlled documents to support business requests.
• Maintain document metadata and ensure accuracy during edits and reviews.
• Conduct quality checks for consistency and regulatory compliance.
• Support inspections and audits by providing requested documents.

Skills

Attention to detail

Document control

Verbal & written communication

Workflow management

Education

High school/GED + 2 years related experience

Associate’s + 6 months related experience

Bachelor’s degree

Tools

CDOCS

Job description

Amgen is seeking an Associate Quality Compliance professional to support the R&D Quality Management System. You will manage controlled documents like SOPs and work instructions, ensuring development, maintenance, and retirement align with global standards and GCP regulations.

You will collaborate across functions to drive approvals, perform quality checks, and help maintain inspection readiness. A strong emphasis on detail, communication, and workflow management is required.