Document Control Quality Assurance

**** ****** *****. *****, ** . Phone 216-***-****

***********@*******.***

Kelly Clifford

Objective

To obtain a position where I can maximize my management skills,

organizational skills, internal and external documentation control, LEAN

techniques and training experience.

Work Experience

I have 9 years of experience working in Quality Assurance, specifically

within Document Control. 3 years experience as a Supervisor, managing both

Change Control Coordinator (External Changes) and Document Control

Coordinator (Internal Changes). I have obtained my CMIIB certification

(Configuration Management Basic Certification) June 2012. I have been

trained on Lean/Six Sigma internally within Affymetrix and also worked with

a team to complete a Lean project regarding the Change Order process

(2009/2010). I am a current member of ASQ. I am able to work independently

as well as a part of a team. I have shown the ability to see any project

thru from inception to completion. I have experience working in a war room

for FDA Audits as well as speaking on behalf of Document Control during TUV

audits. I have knowledge of controlling MRP systems as well as electronic

document management systems. I have also been trained by an outside

trainer on Internal Auditing.

Work History

March 2013 - Present Affymetrix, Inc. Warrensville Heights, Ohio

Associate Mgr, Document Control

. Managed Change Control Coordinator and Document Control Coordinator

. Worked with outside consultants in order to get site ready for FDA

audits regarding new IVD products

. Continuously improved processes and worked on multiple Kaizen events

with successful completion.

. Super User of electronic document repository/electronic change order

system, SharePoint

February 2010 - March 2013 Affymetrix, Inc. Warrensville Heights, Ohio

Supervisor, Document Control

. Supervise Change Control Coordinator and Document Control Coordinator

. Assisted with the transition from ISO 9001 to ISO 13485

. Set up Document Control for readiness for ISO 13485

. Assisted with Corporate Training Management System Project to create

one system for training records (electronic)

. CO flow and implementation follow-through

. Organize, maintain, and manage SharePoint Document Management System

to meet the needs of all departments.

. Monitor adherence to FDA requirements for GMP and ISO 13485

. Internal auditor training/completed internal audits

September 2008 - February 2010 Affymetrix, Inc. Warrensville Heights, Ohio

Document Control Specialist

. Assisted in the transfer of Reagent Operations from California to Ohio

. Assisted with technical writing in our first IVD product.

. Update corporate ERP system as needed to implement released Change

Orders

May 2006-January 2008 University Hospitals of Cleveland University Hts,

Ohio

Staff Assistant, Enterprise Staffing Services

. Staffed RN's and Sitters to fill the needs on various floors

. Confirm required documentation for agency staff has been received in

order to comply with standards

. Look over background checks, applications, licensures, etc. for

personnel

2002-May 2006 Codonics, Inc. Middleburg

Heights, Ohio

Document Control Administrator

. Organize, maintain, and manage corporate documentation system to meet

the needs of all departments and outside service centers.

. Monitor adherence to FDA requirements for GMP (ISO 9002)

. Product release, manufacture and maintenance

. Component Specification Criteria and drawings for components and

assemblies

. ECR flow and implementation follow-through

. Temporary Process Deviations

. Product Engineering design control, including part numbering system

. Product safety and EMI compliance

. Update corporate MRP system as needed to implement released

Engineering changes

Education

June 2012 CMIIB Configuration Management Basics Certification

Institute of Configuration Management

1995-1999 Revere High School

Richfield, Ohio

Awards received

Awarded for my ACE Project (LEAN), awarded for key roles in various product

projects, and recognized by fellow employees and managers in continuing

excellence programs

Lean training at our Corporate Facility to complete the ACE Project

70 WPM

Knowledge of Microsoft Access, Outlook, Visio, Frame Maker, PowerPoint,

Adobe, Kronos, SharePoint, JDE, Fourth Shift, and Acrobat

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