Document Control Specialist

Position Purpose: The function of the Document Control Specialist is to update, document, and maintain all quality programs in accordance with departmental procedures.KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS: Process document change requests in the document control system in accordance with procedureEnsure documentation processing is performed properly and within time requirementsMaintain Certificate of Compliance and Lot Information sheetsMaintaininternal documentation logsProcess changes to quality and safety documentation and update as requiredSupport Records RetentionProcess, print, distribute, and reconcile Visual Defect ReferencesMaintain a two-year review of controlled proceduresAssists Compliance Manager during customer auditsPerform special projects as directed by Compliance Manager or Plant Quality ManagerPerforms Periodic ReviewIdentify system(s) inefficiencies that contribute to increased quality costs.Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.Other duties as assignedPOSITION REQUIREMENTS: High school Diploma or equivalentOne year experience in an FDA regulated environment preferredDemonstrated organizational skills and Intermediate to Advanced level knowledge of PC applications such as Microsoft Word, Excel and SAP Database software required.Able to lift up to 30 lbs.Able to push and pull items.Ability to sit, stand and walk 80% of shift.PREFERRED KNOWLEDGE/SKILLS:Excellent communication skills with the ability to understand, read, write, and speak EnglishAbility to work without direct supervision, stay on task, prioritize department and production needs, and meet daily deadlinesWORK ENVIRONMENT:Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparelAbility to travel between office and production departments as well as company buildings requiredADDITIONAL NOTESThis Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee and may be revised at any time by the Company.