Document Control Coordinator I — Pharma EDMS & QA

americanregent; New Albany (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent seeks a Document Control Coordinator to manage controlled documents and support the EDMS and change control processes. You will edit, review and file records, issue Master Batch Records and assist with regulatory inspections.

The role requires familiarity with cGMP, SOPs, EDMS and strong organizational skills, plus the ability to work independently in a team setting. Training and central archive duties are also part of the scope.

Qualifications

• High School Diploma or GED is required; Associates or Bachelor's Degree preferred.
• 0-1 year of experience in Quality Assurance or Document Control is preferred.
• Minimum 2 years of work experience in a FDA-regulated environment is preferred.
• Must be able to work independently, with minimal supervision.

Responsibilities

• Edit, review, track, issue, scan and file controlled documents in accordance with applicable SOPs and cGMP.
• Maintain revision and maintenance of controlled documents (SOPs, specifications, protocols) within the EDMS.
• Prepare controlled documents through the EDMS and change control process including editing, proofreading, tracking, printing, scanning and filing.
• Issue Master Batch Records to production in accordance with SOPs.
• Provide support for regulatory inspections and partner audits.
• Assist internal departments by requesting controlled copies, updating on reviews, creating EDMS reports and reassigning tasks.
• Ensure all work is performed and documented per cGMP and SOPs.
• Provide training support regarding the EDMS for internal departments.
• Assist in Central Archive document intake, retrieval and maintenance.
• Perform other tasks/duties as assigned by management.

Skills

Communication skills

Teamwork

Independent work

Overtime availability

Education

High School Diploma or GED

Associate's or Bachelor's Degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

American Regent seeks a Document Control Coordinator to manage controlled documents and support the EDMS and change control processes. You will edit, review and file records, issue Master Batch Records and assist with regulatory inspections.

The role requires familiarity with cGMP, SOPs, EDMS and strong organizational skills, plus the ability to work independently in a team setting. Training and central archive duties are also part of the scope.