Document Control Specailist

Company: Manpower Group
Location: Stockton
Posted on: May 6, 2021

Job Description:

Job DescriptionDocument Control Specialist Responsibilities Independently manage and monitor the processing, review, and approval of all controlled documents in document management systems (DMS) and supporting manual systems. Develops and reports document control key performance indicator metrics and change management statistical information to management team as required. Manages GMP records for cataloging, archival, retrieval and scheduled destruction of records in accordance with established procedures. Responsible for driving the timeliness of change control outputs and for ensuring that change control processes are being properly executed in accordance with procedures. Commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities Coordinate the revision process of Standard Operating Procedures (SOPs), forms, and other controlled documents assuring that the corporate and regulatory standards are upheld Manage the daily flow and final release of controlled documents through the document management system. Continuous improvement of the Document Control program Participates in the development and roll-out of document control tools, monitors documentation/Quality Systems function, and coordinates with IT on issues Develops and delivers training regarding document control processes and system changes Maintain master documents and records (both hardcopy and/or electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized Qualifications Bachelor's degree in scientific discipline preferably Life Sciences, but not required Minimum of two (2) Plus years QA document control experience Experience in Document Control System and network-based Quality Management Systems Worked in an FDA regulated environment Working knowledge of ICH/GMP regulations and expectations Proficient in document management systems Highly Proficient in Word, Excel, and PowerPoint - Smartsheet and SharePoint are a plus Associated topics: content, document, documentation, documentation specialist, file, msword, ms office, technical writer, technical writing, writer

Keywords: Manpower Group, Stockton , Document Control Specailist, Other , Stockton, California