Lead Document Coordinator

Company : Regeneron

Job Type : Full Time

County Limerick

Number of Applicants

:

000+

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Job Description - Lead Document Coordinator

Summary: 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. Understands the basic principles and concepts of the documentation lifecycle and associated electronic systems. Performs departmental tasks under limited supervision. Essential Duties and Responsibilities can include, but are not limited to, the following: DOCUMENT STRUCTURE
Develops guidance for document hierarchy concepts and implements changes
Provide guidance for new document type creations based on existing scenarios
Recommends approval strategies to customers including release strategies
DOCUMENT & WORKFLOW MANAGEMENT
Provides guidance to others on day-to-day tasks
Proficient in wide array of departmental activities
Coordinates multiple pre-fixes and/or processes across multiple areas and sites
Owns processes with ability to act as back-up to other processes
Executes tasks associated with EDMS outages
Manages with supervision document requests including intake, coordination, editing, review, and release
Serve as a team member for the Quality System Enhancement Request meetings driving discussions to resolution that is efficient, compliant, and considers all impact
Serve as a team member on the Urgent Workflow meeting driving the discussion to understand the request, it’s urgency amongst other request, potential impact to the business, and final disposition. Track metrics and analyze trends to identify improvement opportunities.
RECORD ISSUANCE
Executes the different steps associated with the lifecycle of one or more records (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
Monitors inventory of issued documentation
PROCESS PERFORMANCE
Performs metrics analysis required for understanding of system or process performance, or investigation activities, and identification of reactive and proactive changes
Authors reports on a pre-defined basis needed to support process understanding, customer information requests, and visibility of organization activities
Generates concepts for displaying data from different departmental activities into visual management tools
Analyzes standing metrics reports for Quality Operations Systems Metrics meeting, Right To Operate meeting, and other performance review meetings. Provides summary of results.TECHNICAL SYSTEMS
Possesses strong understanding of the Electronic Document Management System EDMS for processing workflows, running reports, and performing information searches. Guides others in the access and use of the EDMS.
Monitors and manages one or more QlikSense tools, FileMaker Pro Databases, The Document Activation Management tool, Sharepoint sites, and Servers.
INSPECTION SUPPORT
Serves as integral resource or team member for regulatory and internal audit and inspection logisticsCOMPLIANCE SUPPORT
Leverages subject matter knowledge to assist in problem solving and investigation efforts
Guides/leads investigations at the NOE level. May support investigation at the EOE level.
GENERAL
Identify areas for continuous improvement for processes based on experience and customer feedback.
Act as a team member in site-wide, cross-functional project teams. May lead departmental projects.
Lead-Related Activities include, but are not limited to, the following:
Provides on-the-floor guidance and support to employees.
Ensures employees timesheets are completed on time.
Monitors employees training to ensure that all requirements are met, including OJT.
Maintain up to date training records for self and direct reports.
Perform minimally monthly performance feedback meetings with direct reports.
Escalates all performance issues to management and/or HR.
Education and Experience:
Bachelor’s degree with 3+ years relevant experience or Equivalent combination of education and experience
Must have demonstrated people lead experience
Knowledge, Skills, and Abilities:
Knowledge of document databases and other electronic document management tools (e.g. eDocCompliance, FileMaker Pro).
Attention to detail and organizational skills.
Ability to work independently with moderate supervision.
Ability to work in a team environment.
Ability to work well under time restraints.
Experience with Microsoft Office - Word, PowerPoint, Excel, Access, and Outlook.
#LI-Onsite #REGNIEQA #JOBSIEPR #IRELIM 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.