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QA Document Coordinator

Company: Frederick National Laboratory for Cancer Research
Location: Frederick
Posted on: September 30, 2019

Job Description:

The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I and II clinical trials targeting a range of infectious diseases. KEY ROLES/RESPONSIBILITIES Receive, scan, sort and file documentation according to the organizational filing system (electronic and paper-based) Develop and maintain electronic and paper file structures Use and understand the electronic document management system (eDMS) to file/retrieve electronic documentation Format and route documentation for review and/or approval via the electronic workflow process or paper-based system Provide access to documentation for employees Prepare documentation to be shipped to the off-site storage vendor Support the day-to-day activities of the document control group, such as copying, printing, and setting up folders for filing documentation in the record centers Create logbooks Assist in the writing of standard operating procedures (SOPs) Issue and reconcile GMP controlled documents (e.g., production batch records, validation protocols, etc.) Track and reconcile documentation via logbooks and Excel spreadsheets BASIC QUALIFICATIONS Possession of a high school diploma or equivalent; foreign degrees must be evaluated for U.S. equivalency In addition to the educational requirements, a minimum of two (2) years related experience including one (1) year at the level of Document Coordinator/Processor I Ability to understand and navigate complex file structures and set up and maintain filing systems Ability to operate a variety of office equipment (e.g. computer, fax, scanner, copier, printer) Knowledge of common office practices and procedures: typing, filing, scanning, English grammar, punctuation, spelling and abbreviations Microsoft Office (Work, Excel and Outlook) Internet Explorer Must be able to obtain and maintain a security clearance PREFERRED QUALIFICATIONS Previous experience as a document coordinator, secretary, or administrative assistant An understanding of controlled documentation Previous experience in GCP, GLP, or GMP regulated environment Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

Keywords: Frederick National Laboratory for Cancer Research, Frederick , QA Document Coordinator, Other , Frederick, Maryland

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