Document Control Assistant - 2nd Shift

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

Description

The Document Control Assistant is responsible for administering the processes and practices which support documentation compliance. The Specialist will work in a pharmaceutical production facility and in close collaboration with Quality Assurance, Quality Control and Production with a key‑focus on documentation accuracy, quality and integrity.

Essential Functions

• Manage document control processes through electronic systems and/ or paper‑based systems. Distribute approved documentation to appropriate personnel, track receipt of documentation and notebooks.
• Maintain lists and postings required for both electronic and hard copy; maintain specific databases in Document Control Department and training records.
• Perform data entry and management in systems (Document Compliance and Process Compliance) and maintain the print/soft copies for all documents.
• Collaborate with teams to complete, maintain an up‑to‑date Document Control System.
• Store, archive, and retrieve versioned documents such as certificates of analysis of materials and products, specifications, methods, protocols, and report files.
• Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols, and other controlled documents.
• Track document approvals and related activities, ensuring online documents are updated and accurate.
• Work with other departments to clarify and correct documentation to ensure compliance.
• Organize and maintain the work area and keep up‑to‑date files.

Additional Responsibilities

• Prepare documentation for third‑party inspection/audits.
• Assist validation and regulatory department with documentation and various requirements.