Document Control Manager
Resume:
Cathie Perkins Document Management Professional
**************@*****.*** www.linkedin.com/in/cathie-perkins-bb22a47 530-***-**** Hayward, CA 94544
A top-performing Documents Management Professional with extensive experience in team leadership and quality assurance. Highly skilled in leveraging technological platforms and databases to ensure accurate document creation and control, maintaining adherence with overarching policies, procedures, and best practices. Spearhead cross-functional team through clear channels of communication and collaboration, ensuring effective training and support for innovative systems. Evaluate existing operations and systems to implement strategic improvements and upgrades designed to streamline operations and improve workflow.
Areas of Expertise include:
Document Management
Process Improvement
ISO 13485
Database Administration
Team Leadership
MS Office Suite, Visio, QSR, GMP
Quality Assurance/Control
Standard Operating Procedures
Strategic Planning & Analysis
Training & Development
MasterControl, Adobe Acrobat, Epicor
FDA 21 CFR Part 820/Part 11
Professional Experience
ALLERGAN INC. Pleasanton, CA Jul 2017 – March 2018
Documentation Manager
Oversee daily workflow for change control process based on organizational needs. Responsible for maintenance, processing, and control of all documents including development, production, and records management or all cGxP operations. Control and order external standards. Compile device history records, design history files and validation files. Support back-room audits for Quality System Audits, as well as internal audits, providing documentation, logs, binders, and processes to ensure accuracy and completeness. Facilitate documentation and closure of Corrective Actions and Deviations.
ABAXIS INC. Union City, CA Jul 2015 – Jul 2017
Document Control Program Manager
Conducted all sub-administrative functions for the automated web based system. Led one document control specialist in daily operations for change control processes. Coordinate translation services for products pertaining to documentation. Handle control and ordering of external standards. Managed off-site document storage and shredding, as needed, as well as backroom audit support for USDA and Quality System Audits. Maintained device history records, design history files, and validation files.
Key Accomplishments:
Successfully configured, validated, integrated, and implemented MasterControl V11.4.0, maintaining compliance to 21 CFR Part 11.
GENER8 Sunnyvale, CA Jul 2013 – Jul 2015
QA Consultant
Collaborated with MasterControl services to develop and execute Performance Qualification Testing. Identified and addressed NCR backlog and maintained system for consistent updates. Supported all QA and QC activities, compiling Quality System-related documentation as needed. Liaised with customers for all issue resolution and inquiry response.
Key Accomplishments:
Spearheaded MasterControl Validation Project for the implementation of MasterControl V11.1.0.
Established QA processes for device history record review/lot release and equipment calibration.
GENTURALDX Hayward, CA Dec 2011 – Nov 2012
Document Control Manager
Oversaw document control system and established and managed product QA processes including DHR review, lot release and equipment calibration. Supported quality system requirements for various processes, running back room for audits and presented document control and production QA processes and records as needed.
Key Accomplishments:
Created and maintained DHF files and collaborated with product development teams to ensure adherence to ISO 13485 and FDA regulations.
ALERE INC. San Diego, CA Apr 2009 – Nov 2011
Quality System Administrator/Document Control Supervisor
Led a team of five document control specialists though daily operations, implementing a web-based document control system and maintenance. Prepared documentation for MasterControl Software validations and executed PQs. Evaluated effectiveness of document processing system. Oversaw product and equipment validation and qualification programs through tracking number assignment, signature cycle, and archive. Maintained Device History Records, Quality Control Records, and Bill of Materials Records. Administered web-based document control systems.
Key Accomplishments:
Standardized operating procedures through comprehensive, web-based automated training initiatives for 900+ employees.
Previous positions include Document Control Manager for Cholestech Corp., ISO Management Representative for Matheson Tri-Gas, and Training Supervisor for LSI Logic.
Training
MasterControl SysAdmin Training, 2013
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