Associate Document Coordinator

We are currently looking to fill a Document Coordinator position. This position provides support to the process for crafting, reviewing, approving, distributing, controlling and maintaining documentation to ensure effective and efficient application of GMP. Documentation within this process includes, manufacturing and packaging, laboratory, and general operations. Understands the basic principles and concepts of the documentation lifecycle and associated electronic systems. Performs departmental tasks under supervision.

Available Work Schedules are:
• Monday-Friday, 8:00am-4:30pm
• Monday-Friday, 1:30pm-10:00pm

In this role, a typical day might include the following:
• Understanding the concept of document hierarchies and applies when executing document review
• Performs document review against standard formats and requirements
• Understands the approval process and provides advice to customers
• Ensures appropriate cross-referencing, links, and other required meta-data for documents
• Perform intake review of documents for completeness and accuracy while maintaining document workflow
• Coordinate review and revision of controlled documents
• Owns single to a few pre-fixes or process across multiple areas within a site
• Executes activities associated with creation, retiring and unretiring, and periodic review of documents
• Processes document requests including intake, coordination, editing, review, and release
• Ensures collaborative review is completed prior to workflow activation
• Maintains document integrity as per procedure
• Performs basic troubleshooting of workflows
• Executes 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 correct
• Maintains an accurate and comprehensive inventory of issued documentation
• 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
• Builds basis visual management information from data for different department 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
• Maintain departmental databases
• Participates in inspection and audits by supporting the associated logistics
• Supplies requested information to Doc Control inspection team
• Participates in investigations
• Identify areas for continuous improvement for processes based on experience and customer feedback
• Participate in departmental project teams

This role may be for you if you:
• Have knowledge of document databases and other electronic document management tools
• Have attention to detail and organizational skills
• Are able to work independently with moderate supervision, as well as in a team environment
• Are able to work well under time restraints
• Have strong Microsoft Office skills

To be considered for this role you must hold a Bachelor's degree and the following minimum amounts of relevant experience for each level:
• Associate Document Coordinator - 0-2 years
• Document Coordinator - 2+ years
• Sr Document Coordinator - 4+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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