R&D Quality Compliance: Document Control Specialist

Initial Therapeutics, Inc.

Washington (District of Columbia)

On-site

USD 70,000 - 90,000

Full time

6 days ago

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Benefits offered by this job

Retirement plan

Medical/dental/vision benefits

Stock-based incentives

Bonus program

Job summary

Amgen in the Washington, DC area is seeking an Associate Quality Compliance to support the R&D Quality Management System. You will execute controlled document workflows, maintain metadata in CDOCS, perform impact analyses, and ensure documents meet global standards and GCP regulations.

You will collaborate across functions to drive document approval, conduct quality checks, and assist inspections. This role offers a growth path within a collaborative, science-driven environment focused on

Qualifications

High school/GED with 2 years of related experience OR Associates + 6 months related experience OR Bachelor's degree.
Bachelor's degree in a related field is acceptable.
Strong attention to detail with proven ability to perform quality control reviews.
Excellent verbal and written communication skills.
Ability to manage document workflows and prioritize tasks.
Working knowledge of document control tools and best practices.

Responsibilities

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