R&D Quality Compliance: Document Control Associate

BioSpace; Washington (District of Columbia); On-site; USD 70,000 - 90,000; Full time

Job summary

Amgen is seeking an Associate Quality Compliance to support the R&D Quality Management System by maintaining controlled documents such as SOPs and work instructions. You will ensure documents are developed, maintained, and retired per global standards and GCP regulations.

The role involves cross-functional collaboration, performing quality checks, and facilitating approvals to keep inspections ready, with a focus on accuracy and timely delivery.

Qualifications

• High school/GED plus 2 years related experience or
• Associates plus 6 months related experience or
• Bachelor’s degree required

Responsibilities

• Execute and track workflows for creation, revision, and obsoletion of documents in the controlled document management system (CDOCS).
• Perform controlled document impact analysis in support of business requests and initiatives.
• Maintain document metadata in CDOCS.
• Conduct quality checks, editing, and proofreading of documents for consistency and compliance.
• Monitor document workflows, notify stakeholders of pending tasks, and follow up to ensure timely completion.
• Support inspections and audits by retrieving and compiling requested documents.

Skills

Attention to detail

Document control tools

Verbal communication

Written communication

Workflow management

Education

High school diploma or GED

Associate degree

Bachelor's degree

Tools

None

Job description

Amgen is seeking an Associate Quality Compliance to support the R&D Quality Management System by maintaining controlled documents such as SOPs and work instructions. You will ensure documents are developed, maintained, and retired per global standards and GCP regulations.

The role involves cross-functional collaboration, performing quality checks, and facilitating approvals to keep inspections ready, with a focus on accuracy and timely delivery.