Document Coordinator

Role Summary

Document Coordinator at Regeneron supporting the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure GMP compliance across manufacturing, packaging, laboratory, and general operations. Applies understanding of the documentation lifecycle and electronic systems.

Responsibilities

• Performs document review against standard formats and requirements and ensures appropriate cross-referencing, links, and other required meta-data for documents
• Processes document requests including intake, coordination, editing, review, and release
• Implements the steps of the documentation lifecycle for records such as Master Batch Records, Batch Sheets, Protocol Performance Copies, Labels, Logbooks, Keys: issuance, tracking, and reconciliation
• Verifies records ensuring information is present, accurate, and compliant prior to issuing to receiving area
• Collects and compiles data to support metric analysis for system or process performance or investigation activities
• Generates reports and interprets data to support process understanding, customer information requests, and visibility of organization activities
• Runs standing metrics reports for Quality Operations Systems Metrics, Right To Operate, and other performance review meetings
• Maintains a basic understanding of the Electronic Document Management System (EDMS) for processing workflows, running reports, and basic searches
• Accesses and reviews QlikSense tools, file tracking P Databases, the Document Activation Management tool, SharePoint sites, and servers to support task execution
• Participates in inspections and audits by supporting related logistics

Qualifications

• Required: Bachelor‚Äôs in a related field; Assoc. Document Coordinator: 0-2 years; Document Coordinator: 2+ years; Sr. Document Coordinator: 4+ years
• Preferred: Experience in a quality-driven organization; understanding of biologics manufacturing operations; ability to learn and utilize computerized systems; organized with attention to detail; ability to prioritize multiple assignments and changing priorities

Skills

• Document control systems and EDMS proficiency
• Data collection and metric analysis
• Report generation and data interpretation
• Process documentation and lifecycle management
• Systems navigation (QlikSense, SharePoint, databases)

Education

• Bachelor‚Äôs degree in a related field (level dependent on experience)

Additional Requirements

• Shift: 2nd Shift: Sunday-Wednesday, 1pm-11:30pm
• Travel: None specified