Document Control Assistant - 2nd Shift

Amneal; Piscataway Township (NJ); On-site; USD 42,000 - 62,000; Full time

Job summary

Amneal is seeking a Document Control Assistant to support documentation compliance within a pharmaceutical production facility. You will manage document control processes, distribute approved docs, and maintain training records, ensuring accuracy and integrity across electronic and paper systems.

You will collaborate with QA, QC and Production to keep the Document Control System up to date, store and retrieve versioned documents, and prepare controlled documents for audits and inspections.

Qualifications

• Experience in document control within a pharmaceutical environment.
• Proficient with electronic and paper-based document management.
• Ability to maintain training records and related databases.
• Strong collaboration with QA, QC and Production teams.

Responsibilities

• Manage document control processes through electronic systems and/or paper-based systems; distribute approved documentation to personnel; track receipt of documents and notebooks.
• Maintain and update lists for electronic and hard-copy records; manage databases in Document Control and training records.
• Perform data entry and management in Document Compliance and Process Compliance systems; maintain print/soft copies.
• Collaborate with teams to keep the Document Control System up to date and compliant.
• Store, archive, and retrieve versioned documents (COAs, specs, methods, protocols, reports).
• Prepare and distribute PBRs, Packaging Batch Records, SOPs, methods and protocols.

Skills

Data entry

Document control

Attention to detail

Communication

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.