Sr. Document Coordinator

Regeneron Pharmaceuticals • Rensselaer, NY

88d • $28 - $43

About The Position

The Document Control department at Regeneron is adding to their team! The Sr. Document Coordinator provides support to the process for creating, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP. Documentation within this process includes, but is not limited to, manufacturing and packaging, laboratory, and general operations. This individual should understand the basic principles and concepts of the documentation lifecycle and associated electronic systems. Shift available: Monday - Friday, 8am-4:30pm.

Requirements

• Bachelor's in a related field.
• 4+ years of relevant experience, may substitute proven experience for education requirement.
• Understanding of biologics manufacturing operations.
• Ability to learn and utilize computerized systems for daily performance of tasks.

Nice To Haves

• Excel in a quality driven organization.
• Organized and have an attention to detail.
• Can prioritize multiple assignments and changing priorities.

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.

Benefits

• Health and wellness programs.
• Fitness centers.
• Equity awards.
• Annual bonuses.
• Paid time off for eligible employees at all levels.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree