Documentation SpecialistShift: 10:30 am - 7 pm. Must be available to work overtime and weekends based on business needs.Documentation SpecialistProcesses documents received in the area through the Document Management System.Adds/reviews document properties in the system.Approves documents and system properties and releases them for distribution.Circulates change management packages for review and approval, monitors approver responses, and ensures all required approvals are obtained.Completes work according to established priorities, policies, practices, and procedures to ensure documentation is issued per schedule.Verifies the impact of procedural changes on various operational systems such as SAP, LIMS, MES/POMS, and DeltaV.Verifies synchronization of changes between operational systems and documentation systems.Coordinates document changes across shared sites (Worcester, ABL, and Singapore plants).Trains employees on system techniques and procedures.Receives, evaluates, and assigns effective dates for documents.Communicates status of procedures and change requests (CRs) to initiators and negotiates implementation timelines when necessary.Performs proofreading of documents received by the documentation area.Verifies and receives documents, notifies affected areas and Training department of changes.Executes changes in operational systems such as SAP and DSP.Troubleshoots conflicts in the Document Management System or operational systems.Prepares/reviews manual PCRs for use in SVP (Small Volume Parenteral) and BDS (Bulk Drug Substance) areas.Manages the retention room and coordinates document transfer to Iron Mountain.Supports operations in Environmental, Health & Safety (EH&S) systems and promotes continuous improvement.Education RequirementsAssociate degree in Secretarial Sciences, Business Administration, or Natural Sciences with 3 years of experience, ORHigh school diploma or GED with 5 years of experience in document control.Experience RequirementsMinimum of 3 years of experience in document control.Work EnvironmentPhysical: Office environmentSocial: Continuous interaction with multiple departments such as Validation, Training, Quality, Production, Engineering, IS, etc.Interacts with staff from non-exempt level to plant management, as well as documentation representatives from Worcester and the division.Intake Call Requirements Required Experience / EducationMinimum 3 years of experience in QA documentation OR Associate/Bachelor's degree.Top Skills RequiredProcessing documents through a document management system.Circulating change management packages and ensuring required approvals are obtained.Preparing/reviewing manual PCRs for SVP and BDS areas.Managing document retention room and coordinating transfers to Iron Mountain.Verifying impact of procedural changes on systems such as SAP, LIMS, MES/POMS, DeltaV.Additional Skills (Nice to Have)Knowledge of AttacheProStrong proficiency in Client Word and ExcelBilingual (English/Spanish)Work Environment TypeCombination of individual and group work settings
Documentation Specialist • Barceloneta, PR
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