Job Description

We are seeking an experienced Document Controller to support document management and control activities within a regulated pharmaceutical manufacturing environment. This individual will be responsible for maintaining accurate, compliant, and controlled documentation while supporting Quality, Engineering, Validation, Manufacturing, and other cross-functional teams.

Document Controller Responsibilities

• Manage the creation, routing, review, approval, issuance, revision, and archival of controlled documents within the electronic document management system (EDMS).
• Utilize Veeva to manage document workflows, approvals, revisions, and document lifecycle activities.
• Ensure controlled documents are accurate, current, properly formatted, and maintained in accordance with established procedures and cGMP requirements.
• Support document control activities for SOPs, work instructions, specifications, protocols, reports, forms, and other GxP documentation.
• Coordinate document reviews and approvals with Quality, Engineering, Validation, Manufacturing, and other stakeholders.
• Track documents through the approval process and follow up with document owners and reviewers to ensure timely completion.
• Maintain document histories, revision records, effective dates, and appropriate archival of superseded documentation.
• Perform quality checks of documentation for completeness, accuracy, formatting, and compliance with Good Documentation Practices (GDP).
• Assist with document retrieval and preparation for internal audits, regulatory inspections, and project activities.
• Support continuous improvement of document control processes and procedures.

Requirements

• Previous Document Control experience within the pharmaceutical, biotechnology, or other highly regulated life sciences industry required.
• Hands-on experience with Veeva, preferably Veeva Vault QualityDocs or a similar Veeva document management application, required.
• Knowledge of cGMP and Good Documentation Practices (GDP).
• Experience managing controlled documents and electronic document workflows.
• Strong attention to detail with excellent organizational and time-management skills.
• Ability to manage multiple documents, priorities, and deadlines simultaneously.
• Strong written and verbal communication skills with the ability to work effectively across multiple functional groups.
• Proficiency with Microsoft Office applications.
• Ability to work onsite in West Chester, Ohio.