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Document Control Manager

Hayward, California, 94544, United States
April 22, 2018

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Cathie Perkins Document Management Professional 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.


MasterControl SysAdmin Training, 2013

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