Document coordinator

The Document Control department at Regeneron is adding to their team! The 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 :

2nd Shift : Weds-Sat, 1pm-11 : 30pm

The day to day of an Document Coordinator could include, but are not limited to, the following :

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

To be considered for the Document Coordinator position you must have a Bachelor’s in a related field with the following minimum amounts of relevant experience for each level :

Assoc. Document Coordinator : 0-2 years

Equivalent combination of education and experience in lieu of education requirements.

REGNQA

Last updated : 2024-05-21