Karen Louise Karie

480-***-**** acx2g4@r.postjobfree.com

SUMMARY OF SKILLS

§ Document control

§ Retrieval of data and report generation

§ Knowledge of ISO and FDA regulatory compliance

§ Direct support to staff and management

§ Working knowledge of Microsoft Excel, Word, Outlook, SharePoint LAB SUPPORT/GOOD HEALTH MANUFACTURING 4/2016 – 10/2016 QA Document Control Specialist (contract)

§ Processed Change Control Requests for all types of documents, including SOPs, specifications, forms and templates

§ Maintained files in a manual document control system

§ Recorded approved documents in SharePoint

§ Experience working in a GMP environment or other similar environment NESCO RESOURCE/FOREVER NUTRACEUTICAL 5/2014 – 5/2015 QA Documentation Specialist (contract)

§ Issued and maintained secure access to controlled documents (BPRs, PRs)

§ Reviewed all new and revised controlled documentation for appropriate format, content, and consistency with other documentation

§ Issued approved hard copy documents to designated departments

§ Worked with all departments as needed to ensure documentation requirements were met ULTIMATE STAFFING/STRYKER SUSTAINABILITY 12/2012 – 10/2013 Document Control Coordinator (contract)

§ Processed Engineering Change Orders (ECO) from initiation to implementation

§ Experienced working with Electronic Documentation Management System (EDMS) and SharePoint

§ Reviewed documents for thoroughness, precision and clarity

§ Assisted in maintaining Master Documents lists

AEROTEK/PROCHEM 6/2011 – 1/2012

Document Control Representative (contract)

§ Provided secondary support for document control management

§ Assured compliance with regulations and standards established by regulatory agencies

§ Coordinated and performed document change process of controlled documents such as SOPs, forms, work instructions, and other quality documents

§ Maintained electronic log of controlled documents, templates, and related records

§ Ensured documents were complete, concise, accurate, and conform to established formats AEROTEK/EVEREST COLLEGE ONLINE 4/2011 – 6/2011

Document Control Representative (contract)

§ Responsible for screening current SOPs to be edited and verified that all documents were up to date and compliant with new education reform policies

§ Worked with multiple sites to identify and review policy and SOP gaps

§ Identified inconsistencies and errors and drafted amendments to existing policies & SOPs

§ Drafted new policies as needed

Karen Louise Karie

480-***-**** acx2g4@r.postjobfree.com

AMERICAN MEDICAL SYSTEMS 6/2006 – 6/2010

Document Control Specialist/QA Support

§ Coordinated the approval and release of all new or changed documents used within the Quality System

§ Maintained Engineering Change and Document Change Notice systems, DHRs

§ Implemented and/or maintained engineering drawing and document control systems

§ Interacted with engineering, manufacturing, and marketing departments to ensure they were trained and prepared for regulatory assessments

§ Directly supported Regulatory Manager and assisted with gathering and verifying documents needed for ISO audits

§ Ensured that appropriate changes were documented per existing Document or Engineering Change Notice systems

§ Maintained database for all revision-controlled documents, including drawings, reports, and engineering documentation

§ Updated master list of drawings, documents, logs, and databases COMTECH EF DATA 7/2003 – 4/2006

Document Control Clerk/Engineering Support

§ Data entry and updates of new CEFD, Purchased Part numbers and Bill of Materials in ROI data base

§ Reviewed and processed ECOs and RCOs on a daily basis

§ Compiled and scanned drawings to PDF, maintained control records and related files to release drawings and engineering documents to manufacturing and other operating departments

Education

UNITED STATES ARMY RESERVE: Combat Medical Technician School, Fort Sam Houston, TX EMT and General Medical Training

UNITED STATES AIR FORCE RESERVE: Air Technical Command School, Keesler A. F. Base, MS Information Systems Control Specialists Course

Advanced Telecommunications

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