Document Control Assistant - 2nd Shift

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.

• 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.

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