Pharma Document Control & Compliance Assistant

Amneal Pharmaceuticals; Newtown (NJ); On-site; USD 42,000 - 54,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Document Control Assistant to support documentation compliance within a pharmaceutical production setting. The role focuses on accuracy, quality, and integrity of documents in collaboration with QA, QC and Production teams.

Responsibilities include managing electronic and paper-based document control, maintaining databases, data entry, and preparing controlled documents. Ideal candidates will contribute to audits and regulatory readiness while organizing and

Responsibilities

• Manage document control processes through electronic systems and/or paper-based systems.
• Distribute approved documentation to appropriate personnel and track receipt.
• Maintain databases and training records in Document Control.
• Data entry and management in Document Compliance and Process Compliance systems.
• Collaborate with teams to maintain an up-to-date Document Control System.
• Store, archive, and retrieve versioned documents such as COAs, specifications, methods, and reports.
• Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols.
• Track document approvals and ensure online documents are updated and accurate.
• Organize and maintain the work area and keep up-to-date files.
• Prepare documentation for third-party inspections/audits.
• Assist validation and regulatory with documentation requirements.

Job description

Amneal Pharmaceuticals is seeking a Document Control Assistant to support documentation compliance within a pharmaceutical production setting. The role focuses on accuracy, quality, and integrity of documents in collaboration with QA, QC and Production teams.

Responsibilities include managing electronic and paper-based document control, maintaining databases, data entry, and preparing controlled documents. Ideal candidates will contribute to audits and regulatory readiness while organizing and