Pharma Document Control Associate I

American Regent, Inc.; New Albany (OH); On-site; USD 42,000 - 56,000; Full time

Job summary

American Regent Inc. is seeking a Document Control Coordinator to manage controlled documents and EDMS workflows for GMP manufacturing. You will edit, track, and file records, issue Master Batch Records, and assist with inspections while ensuring compliance with cGMP and SOPs.

Collaboration with QA and cross‑functional teams is essential. The role emphasizes accuracy, training support, and timely documentation updates in a regulated environment, with potential growth within the Document Control

Qualifications

• High School Diploma or GED required.
• Associates or Bachelor's degree preferred.
• 0–1 year experience in Quality Assurance or Document Control preferred.
• Minimum 2 years work experience in a FDA regulated environment preferred.
• Ability to perform tasks independently with minimal supervision.
• Excellent organizational and communication skills required.

Responsibilities

• Revise and maintain controlled documents including SOPs, specifications, protocols in EDMS.
• Prepare controlled documents through EDMS and change control process (editing, proofreading, tracking, printing, scanning, filing).
• Issue Master Batch Records to production per SOPs.
• Provide support for regulatory inspections and partner audits.
• Support internal departments by issuing controlled copies and sharing EDMS reports.
• Ensure work complies with cGMP and SOPs.
• Provide EDMS training support to internal departments.
• Assist in Central Archive document intake, retrieval, and maintenance.
• Perform other duties as assigned by management.

Skills

Organizational skills

Interpersonal communication

Written and verbal communication

Teamwork

Independent work

Attention to detail

Education

High School Diploma or GED

Associate or Bachelor's degree preferred

Tools

EDMS

Microsoft Word

Microsoft Excel

Job description

American Regent Inc. is seeking a Document Control Coordinator to manage controlled documents and EDMS workflows for GMP manufacturing. You will edit, track, and file records, issue Master Batch Records, and assist with inspections while ensuring compliance with cGMP and SOPs.

Collaboration with QA and cross‑functional teams is essential. The role emphasizes accuracy, training support, and timely documentation updates in a regulated environment, with potential growth within the Document Control