CYNTHIA L. PETERSON

**** ****** **., #*** • Sunnyvale, CA 94089 • kqjwnh@r.postjobfree.com • 408-***-****

DOCUMENT CONTROL SPECIALIST/ADMNISTRATOR

SUMMARY

Over 20 years of combined Document Control experience in semiconductor and medical device industries. Expertise in the documentation and management of quality systems, including ISO 13485 and GMP guidelines, Microsoft Office, very detail-oriented, and excellent communication and people skills.

PROFESSIONAL EXPERIENCE

Document Control Specialist November 2011 – Present

Curexo Technology Corp. Fremont, CA

• Coordinate the activities of Document Control, including distribution and auditing controlled documents, maintenance of electronic document directories, managing software storage/retrieval, tracking and reporting on document review progress.

• Manage archival activities for controlled documents and validation files to meet requirements of QSR 820, ISO 13485 and MDD.

• Work with subject matter experts on technical subjects in a positive, collaborative manner to prepare controlled documents which conform to defined format.

• Follow SOPs policies and regulations and provide support for the Quality System during corporate audits, actively participating in department activities.

• Responsible for issuing and tracking document change orders (DCO), part numbers, validation and test report numbers.

• Lead Change Control Board (CCB) meeting as required.

• Train new employees on the document control process.

• Training: Update/maintain training program for the company.

• Maintain and audit external standards library.

Document Control Specialist September 2010 – July 2011

MicroAire Surgical Instruments Inc. Palo Alto, CA

(Formerly Coapt Systems)

The same responsibilities as Coapt Systems below.

Regulatory Documentation Specialist June 2010 – Oct 2010

Kelly Services San Jose, CA

Part-Time contract position at Covidien San Jose

Administrative assistant to the Manager and Sr. Specialist of Regulatory Affairs

Responsibilities include updating documents for DCO release using Arena automation software, filing, and creating product binders.

Cynthia L. Peterson • kqjwnh@r.postjobfree.com • 408-***-**** – Page 2

Document Control Specialist July 2007 – May 2010

Coapt Systems Palo Alto, CA

Responsible for the Document Control Department of this medical device company.

• Coordinate the activities of Document Control, including distribution and auditing controlled documents, maintenance of electronic document directories, managing software storage/retrieval, tracking and reporting on document review progress.

• Assigning Lot #’s for Batch Records and compiling Batch Record folders for Manufacturing and Purchasing.

• Training: Update/maintain training program for the company.

• Maintain and audit external standards library.

Documentation Engineering Administrator December 2006 – July 2007

LeCroy, Corp, Santa Clara, CA

Responsible for all aspects of Document Control for this totally automated, paperless department.

• Investigating questionable ECO’s and prototype requests, creating part numbers and entering BOMS, using Lotus Notes and Baan PDM software.

• Assisted in training engineers in the process of creating ECO’s and using Baan PDM.

• Interfaced with Engineering, Materials and Sales.

• This is a remote facility with the corporate office in New York; therefore, it is with very little supervision.

Human Resources Assistant (Temp) September 2006 – December 2006

Cholestech, Corp Hayward, CA

Assisting HR Generalists with general office duties, including:

• Entering all pertinent employee information in HRB Database for new hires, changes and terminations.

Document Control Specialist (Temp) February 2006 – September 2006

Cholestech, Corp Hayward, CA

Responsible for all aspects of Document Control, including:

• Coordinate the activities of Document Control, including distribution and auditing controlled documents, maintenance of electronic document directories, managing software storage/retrieval, tracking and reporting on document review progress.

• Utilized Microsoft Office and FileMaker Pro, MasterControl

• Interfaced with Production, Engineering, Purchasing, Sales and Marketing, Materials and Production Control.

Office Secretary 2004 - 2006

Global Bible Institute Modesto, CA

Responsible for managing the school office

Responsibilities included:

• attending reception desk

• making phone calls and setting up appointments for the dean

• mailing out class information packets, class registration

• placed book orders for all classes

• keeping track of school income, including counting and depositing of all tuition and miscellaneous payments.

Cynthia L. Peterson • kqjwnh@r.postjobfree.com • 408-***-**** – Page 3

• Utilized Microsoft Office, Photo Draw and Microsoft Publisher on a daily basis to fulfill responsibilities and projects.

Other responsibilities included, preparing church membership classes, baptisms, stocking of supplies for the church Welcome Center for the week and weekend activities and services and assisting in other areas of the church as needed.

Document Control Specialist 2001 - 2004

CHOLESTECH, Corp. Hayward, CA

Responsible for all aspects of Document Control, including:

• proofreading, investigating questionable documents, incorporating document changes using Microsoft Office and FileMaker Pro, reproduction, archiving and filing of old revisions.

• Interfaced with Production, Engineering, Purchasing, Sales and Marketing, Materials and Production Control to define deliverables and timeline for completion.

Document Control Specialist 1998 - 2001

INTARSIA Fremont, CA

Created, implemented and managed a document control system for this start-up company.

Document Control Administrator 1996 - 1998

ROCKSHOX, INC. San Jose, CA

Built and updated Bills of Materials on INFIMACS. Processed ECR's using Access for ECR log. Interfaced with Engineering, Purchasing, Sales and Marketing, Materials, and Production Control.

Document Control Clerk III 1991 - 1996

LSI LOGIC, CORP. Fremont, CA

Handled all aspects of Document Control, including running Santa Clara remote facility with little supervision Typed all documents into FrameMaker, distributed all documents to Pilot Line Fab, and maintained all history and current files. Also, incorporated documents into Configuration Management System (CMS) for future total automation of on-line documents.

Document Control Clerk 1990 - 1991

RPC INDUSTRIES Hayward, CA

Managed all Document Control functions. Screened, logged and implemented all ECN’s, Bills of Materials entered on HP Jobscope. Updated release sheets. Sent Vellum drawings to vendor for microfilming on aperture cards for reproduction on OCE machine. Coordinated new projects for Document Control and Drafting.

Document Control Administrator 1987 - 1990

ACRIAN POWER SOLUTIONS San Jose, CA

Processed ECN’s; distributed and maintained current and history files. Incorporated ECN’s on WordPerfect and GEM Draw. Entered BOM’s on VAX and INFIMACS Network System. Interfaced with Drafting, Engineering, Production Control, QA, and Sales/Marketing.

Cynthia L. Peterson • kqjwnh@r.postjobfree.com • 408-***-**** – Page 4

Document Control Coordinator 1987 - 1987

ZILOG, INC. Campbell, CA

Managed all Document Control functions. Also supervised while manager was on LOA for 3 months.

Assistant Buyer 1986 - 1987

COOPERVISION, INC. San Jose, CA

Logged all Purchase Requisitions. Placed orders for lab and office supplies. Typed, distributed, and filed Purchase Orders. Responsible for vendor returns.

Document Control Coordinator 1979 - 1986

ZILOG, INC. Campbell, CA

Responsible for all Document Control functions.

Processed ECN’s checking for accuracy and maintained current and history files. Incorporated ECN’s on Exxon word processor. Distributed controlled documents to all manufacturing areas.

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