Document Control Assistant - 2nd Shift

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 45,000 - 65,000; Full time

Job summary

Amneal Pharmaceuticals LLC in New Jersey seeks a Document Control Assistant to support documentation compliance within a pharmaceutical production facility. You will manage controlled documents, distribute approvals, and maintain training records in collaboration with QA, QC, and Production.

Responsibilities include archiving versioned documents, preparing batch records, SOPs, and ensuring online documents are accurate and up-to-date.

Qualifications

• Experience with document control in a pharmaceutical environment.
• Strong attention to detail and accuracy.
• Ability to manage multiple documents and training records.

Responsibilities

• Manage document control processes in electronic and paper systems.
• Distribute approved documents and track receipt and notebooks.
• Maintain databases and training records in the Document Control Department.
• Archive, retrieve, and version controlled documents (certificates of analysis, specs, methods).
• Prepare and distribute PBRs, batch records, SOPs, methods and protocols.

Skills

Document control

Attention to detail

Data entry

Collaboration

Tools

Document Control System

Process Compliance System

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.