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Document Coordinator

3 months ago

Rensselaer, United States Regeneron Pharmaceuticals, Inc. Full time
Job Description

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.

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

T

his role may be for you if you:

Excel in a quality driven organization

Organized individual with attention to detail

Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally

Ability to navigate changing priorities

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

Assoc. Document Coordinator: 0-2 years

Document Coordinator: 2+ years

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

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (hourly)$20.77 - $37.36