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Job #03639

About our client Our client focuses on the research, development and commercialization of small molecule medicines within various therapeutic areas. Position Location Documentation Specialist California Salary Highly competitive package, commensurate with experience Responsibilities 1) Maintain an effective document control function to ensure compliance with cGMP regulations 2) Assess and recommend quality system improvements, including full utilization of existing technology capabilities 3) Support general QA activities, including deviation and CAPA tracking and trending, batch record review, as needed and employee GMP training 4) Assess document control system, electronic system capabilities and implement system improvements as needed 5) Ensure all document control activities are in compliance with corporate and cGMP requirements 6) Perform new employee and user training for the Livelink Document Management System 7) Develop and format templates for documents, including SOP, specifications, controlled forms and policies that support GxP operations 8) Ensure compliance with regulatory guidelines and the clients’ SOPs 9) Manage proof work and identify errors within documents 10) Ensure timely completion of document control activities within Livelink EDMS 11) Maintain central GxP document records for archiving and timely retrieval 12) Support QA activities such as with batch record review, as needed, trending deviation and CAPA data and ensuring timely completion of CAPAs 13) Recommend and support EDMS related upgrades and system validation activities Requirements 1) BS in Science, Engineering or a related field with 8+ years of experience in the bio/pharmaceutical industry 2) Minimum 5+ years of experience in quality assurance 3) Minimum 3+ years of experience in managing a document control system 4) Experience in establishing and improving document control systems 5) Experience in reviewing manufacturing batch records, deviations and CAPAs 6) Experience in managing an electronic document management system and Livelink a plus 7) Working knowledge of GMP