Pharma Document Control Specialist - Entry Level

American Regent, Inc.; New Albany (IN); On-site; USD 52,000 - 76,000; Full time

Job summary

American Regent, Inc. seeks a detail-oriented Document Control Coordinator to support the EDMS, manage controlled documents, and assist with audits. You will follow SOPs, ensure cGMP compliance, and train internal teams on EDMS processes.

The role requires organization, reliability, and the ability to work with minimal supervision in a fast-paced pharmaceutical environment at our New Albany, IN site.

Qualifications

• High school diploma or GED required; associates/bachelor’s preferred.
• 0-1 year experience in quality assurance or document control preferred.
• 2+ years in FDA-regulated environment preferred.
• Ability to work independently with minimal supervision.
• Microsoft Word and Excel intermediate skills.
• Excellent organizational, interpersonal and written/oral communication.

Responsibilities

• Maintain revision and accuracy of controlled documents in EDMS.
• Prepare controlled documents through EDMS and change control processes.
• Issue Master Batch Records to production per SOPs.
• Support regulatory inspections and partner audits.
• Provide EDMS reports and assist departments with document requests.
• Ensure work adheres to cGMP and SOPs; minimize errors.
• Train internal departments on EDMS usage.
• Assist Central Archive intake, retrieval and maintenance.

Job description

American Regent, Inc. seeks a detail-oriented Document Control Coordinator to support the EDMS, manage controlled documents, and assist with audits. You will follow SOPs, ensure cGMP compliance, and train internal teams on EDMS processes.

The role requires organization, reliability, and the ability to work with minimal supervision in a fast-paced pharmaceutical environment at our New Albany, IN site.