Control Document
Resume:
Stephen Rousseau
San Jose, CA *5148
vr4tsf@r.postjobfree.com
Summary:
Several years Document Control experience
Document Control Specialist / Managing Quality documentation systems and activities. Controlled Document Systems compliant with FDA’s cGMP regulations. Drafting and revising documents, coordinating review and approval. Manage employee training program. Support and participate in Quality functions such as GLP and GCP activities. ECO Analyst with a Product Design background and a passion for reaching releases on time, pursuing a career with a Solid Progressive company. Skilled at working with people, a good addition to any strong team environment and fostering open communications.
Experience:
3 Leaf Systems
3-09 – 11-11
Documentation Specialist
Responsibilities were: Managed Change Control process, Managed the integrity of system data, and facilitated training on PLM system. Managed training throughout Company of controlled documentation. Managed Change control process in PLM system . Help write ECO’s , held CCB meetings if necessary, and expedited approval of all changes.
OptiMedica Corp.
3-08 – 1-09
Documentation Specialist
Responsibilities were: System Administrator – Arena PLM . Managed Change Control process, Managed the integrity of system data, and facilitated training on PLM system. Managed training throughout Company of controlled documentation. Managed Change control process in PLM system . Help write ECO’s , held CCB meetings if necessary, and expedited approval of all changes.
Theravance Inc.
10-2005 – 3-2008
Documentation Specialist
Responsibilities were: Managing Quality documentation systems and activities, these consists of activities related to cGMP, GLP and GCP functions. Drafting and revising documents, coordinating review and approval of documents. Maintain and archive all Quality Controlled documentation. ( SOPs, Test Methods, Specifications)
Track and receive all Change Control activity. (Manage log books, issue process numbers, Compile Batch Records) Point of contact for all QA document related issues.
Xoma Corporation Berkeley, CA
Document Control Associate II
Responsibilities were: Process Change Orders ending with Distribution of Change packages to appropriate persons. Also using the Livelink system to Process, Review and Distribute Engineering Change Orders. Maintain databases in Document Control Group.
Update and archive all electronic documentation in company related to product release.
CDS Engineering ( Temporary through ETG)
2-2004 – 7-2004
Document Control Specialist
Responsibilities were: Process Change Orders, Controlling all Internal & External documentation. Retention of process documentation, process certs, work orders etc..
Maintain Access database’s that regulated most of documentation activity. Use ERP, MRP systems. Interface with all Depts. For any of their documentation needs.
Xoma Corporation Berkeley, CA ( Temporary thru Manpower)
10-2003 – 12-2003
Document Control Specialist
Responsibilities were: Responsibilities were: Process Change Orders ending with Distribution of Change packages to appropriate persons. Also using the Livelink system to Process, Review and Distribute Engineering Change Orders. Maintain databases in Document Control Group. Update and archive all electronic documentation in company related to product release.
Proxium Corporation Sunnyvale, CA
6-2001 – 10-2002
Document Control Specialist
Responsibilities were: Coordinating with Engineering and manufacturing Departments to release and maintain documentation related to product releases and production activity. Used Agile system to process review and distribute Engineering Change Orders. Maintain all systems related to documentation activity.
Polycom Inc. Milpitas, CA
3-1996 – 4-2001
ECO Analyst
Responsibilities were: Process all document changes originating from the Manufacturing and Engineering Departments. Release and maintain documentation related to release and production of products. Create Change packages; implement processes that maintained controlled documentation. Interface with Projects managers, engineers, and marketing personnel with documentation related to product releases and related processes.
Beckman Instruments Palo Alto, CA
3-1986 – 6-1994
Document Control Coordinator
Responsibilities were: ECO processing. Chairperson of Change Control Board meetings. (CCB) Update and archive all electronic documentation in company related product releases. (Drawings, Graphic material, software, user documentation) Maintain ISO documentation in Departments. Member of certified ISO team.
Education:
Michigan State University
1975-1978
Major: Business
Minor: Computer Science
APICS certification 8/93
Production Control
Inventory Control
Skills:
Agile, SAP, Oracle, PeopleSoft, AMAPS, AutoCAD
Livelink, Access, Word, Excel, Illustrator
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