Sr. Document Coordinator

Role Summary

Sr. Document Coordinator at Regeneron supporting the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure GMP-compliant operations across manufacturing, packaging, laboratory, and general operations. Understands the documentation lifecycle and associated 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 different steps associated with the lifecycle of a record (including but not limited to, Master Batch Records, Batch Sheets, Protocol Performance Copies, Labels, Logbooks, Keys): issuance, tracking, and reconciliation
• Performs verification of records ensuring all required information is present, accurate, and compliant against procedures prior to issuing to receiving area
• Collects and compiles data to support metric analysis required for understanding of system or process performance, or investigation activities
• Generates reports and interprets data on a pre-defined basis needed to support process understanding, customer information requests, and visibility of organization activities
• Runs standing metrics reports for Quality Operations Systems Metrics meeting, Right To Operate meeting, and other performance review meetings
• Maintains a basic understanding of the Electronic Document Management System EDMS for processing workflows, running reports, and performing basic information searches
• Accesses and reviews QlikSense tools, file tracking P Databases, The Document Activation Management tool, SharePoint sites, and Servers to support execution of tasks
• Participates in inspection and audits by supporting the associated logistics

Qualifications

• Required: Bachelor‚Äôs in a related field with 4+ years of relevant experience (may substitute proven experience for education)

Skills

• Excel in a quality driven organization
• Understanding of biologics manufacturing operations
• Organized with strong attention to detail
• Ability to prioritize multiple assignments and changing priorities
• Ability to learn and utilize computerized systems for daily performance of tasks