Sr. Document Coordinator

Regeneron Pharmaceuticals, Inc; City of Rensselaer (NY); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biotechnology company in Rensselaer, NY, is seeking a Sr. Document Coordinator to support the documentation process. You will ensure that documents are created, reviewed, and maintained in compliance with GMP. The ideal candidate should have a Bachelor's degree and 4+ years of relevant experience, attention to detail, and the ability to prioritize multiple assignments. The position offers competitive pay and comprehensive benefits.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• 4+ years of relevant experience, may substitute proven experience for education requirement.
• Excel in a quality-driven organization.
• Able to learn and utilize computerized systems.

Responsibilities

• Perform document review against standard formats and requirements.
• Implement lifecycle steps associated with records.
• Generate reports and interpret data.
• Participate in inspections and audits.

Skills

Attention to detail

Organizational skills

Understanding of biologics manufacturing

Ability to prioritize tasks

Education

Bachelor's degree in a related field

Job description

Overview

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.

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 / What You Bring

• Excel in a quality driven organization

• Have an understanding of biologics manufacturing operations

• Are organized and have an attention to detail

• Can prioritize multiple assignments and changing priorities

• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for the Sr. Document Coordinator position you must have a Bachelor’s in a related field with 4+ years of relevant experience. May substitute proven experience for education requirement.

Shift

Monday - Friday, 8am-4:30pm

Apply

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!

Equal Opportunity

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.

Salary

Salary Range (hourly):

$28.03 - $43.80