R&D Quality Compliance Associate – Document Control

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

Benefits offered by this job

Competitive salary

Total Rewards package

Flexible work options where possible

Job summary

Amgen is seeking a Controlled Documentation Associate to support the R&D Quality Management System by managing controlled documents, ensuring SOPs and work instructions comply with global standards and GCP regulations.

You will collaborate across functions to drive approvals, perform quality checks, and assist with inspection readiness. The role emphasizes attention to detail, timely task completion, and robust documentation practices within a dynamic biotech setting.

Qualifications

• High school/GED with related experience or equivalent combinations.
• Associate’s with related experience or a bachelor’s degree.
• Bachelor’s degree preferred for higher responsibility.

Responsibilities

• Execute and track document workflows in CDOCS.
• Perform controlled document impact analysis.
• Maintain document metadata in the system.
• Conduct quality checks, editing, and proofreading.
• Monitor workflows and notify stakeholders of pending tasks.
• Support inspections and audits by retrieving documents.

Skills

Attention to detail

Verbal and written comms

Document control workflows

Priority management

Education

High school/GED

Associate's

Bachelor's

Tools

CDOCS

Job description

Amgen is seeking a Controlled Documentation Associate to support the R&D Quality Management System by managing controlled documents, ensuring SOPs and work instructions comply with global standards and GCP regulations.

You will collaborate across functions to drive approvals, perform quality checks, and assist with inspection readiness. The role emphasizes attention to detail, timely task completion, and robust documentation practices within a dynamic biotech setting.