Document Control Specialist
CurrentPrimarily responsible for the modification, implementation, and effectiveness of all controlled documents within the Pfanstiehl Quality Management System (QMS). Among the responsibilities being managed:Completed Document Change Requests (DCRs) for standard operating procedures (SOPs), specifications, batch production records (PBRs), analytical packets, forms and all controlled documents within the Quality Management System (QMS). This includes assignment of DCR numbers, creation of new DCR numbers, document tracking, and routing for approvalsProcessed pending documents to effective, which also includes sending out weekly reports of new effective documents and logging into LMS. This also includes archiving documents upon requests and updating in LMSCoordinator for quality assurance and regulatory affairs for revised and approved documentsGenerated new document numbers in DMS per procedural requirementsTracking and creating protocol number based on document type (validation, engineering)Supported batch production record and issuance to manufacturing as required:Generated lot numbers in SFC and tracking lot numbers assigned, including the documentation of the product code, document number, process type (validation, stability or routine)Printing batch records in QCS with the new lots created into SFC, ensuring the lot numbers are present on each page and document is properly paginatedLinking new lot numbers into D365 to complete production release for manufacturing useBack up support for the release of PBRs, revising analytical worksheets and the generation of Certificate of AnalysisOn site and remote Audit support:Retrieval of document requests in a timely manner. Active contributor discussing the validated and controlled systems used at Pfanstiehl, demonstrating a walkthrough of the functional areas in PLIAPPS which include, lot number creation and documentation, PBR printing and issuance, generation of new documents and creating an effective document