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Document Control Management

Location:
Tampa, Florida, United States
Posted:
September 24, 2018

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HIGHLIGHTS

I am dedicated and detailed oriented. Experienced background in Document Control with companies certified to ISO13485;2016 Medical Devices, ISO9000, MIL-PRF-38534, AS9100. Proficient in Configuration Management, Record Keeping, Agile 9.3 (PLM) and Omnify 6.0 administration. I am accomplished at leading and working in multitasking work groups as well as individual projects. Fluent in English and Spanish.

WORK EXPERIENCE

PACIFIC BIOSCIENCE LABORATORIES, INC. (LOREAL CLARISONIC)

17275 NE 67th Ct Redmond, WA. 98052 (March 13, 2017 to February 6, 2018)

Document Control Manager / Configuration Management / Omnify Administrator

Maintain the BQMS controlled documents within the Omnify PLM system

Create, maintain and provide support for user accounts and workflows within Omnify PLM

Create, process and release Engineering Changes for Drawings, Specifications, Bill of Materials, Finished Goods

Create new parts and manage the configuration within the PLM and ERP system

Create and process changes for new Finished Goods in ERP using SAP Wise/Lite

Maintain KPI Quality Reports (Cycle Time)

Provide released documentation for suppliers

PHILIPS ORAL HEALTHCARE

22100 Bothell Everett Hwy Bothell, WA. 98021 (May 16, 2011 Adecco; July 5, 2011 to March 1, 2017)

Document Control Lead / Change Analyst / Agile Administrator

Lead the Document Control Department and team of Change Analysts

Maintain the BQMS controlled documents within the Agile PLM system for OHC (Sonicare)

Manage Agile 9.3 PLM application for over 500 users worldwide

Process Engineering Changes for the release of Drawings, Specifications, Bill of Materials, Finished Goods

Create and maintain new parts using applications i.e. AC2M/eCore/Cemafore

Create and maintain accounts within Agile PLM and other applications

Maintain ISO 13485 Medical Device and FDA compliance within the BQMS

Provide frontline user support and training on Document Control and Agile methodologies

AEROJET

11411 139th Place N.E. Willows Road Redmond, WA. 98052 (March 22, 2010 to May 11, 2011)

Teamcenter Technical Data Mgmt / Document Control Asst. / Configuration Management Analyst

Support Configuration Management using Teamcenter Enterprise for drawing/document releases and updates

Support Document Control for part/drawing/document releases and updates within the MRP database

New part entry, document release notification, drawing cataloging, filing, and archival data file maintenance

Prepare ECNs for CRB review meetings

SKILLS INCORPORATED

715 30th Street NE Auburn, WA. 98002 (Apr 28, 2008 to March 19, 2010)

Document Control Specialist/Corrective Action Administrator

Manage Quality System electronic document files and external specifications, drawings, and standards procured for the manufacturing and finishing of aerospace and commercial products per AS9100/NADCAP

Monitor the Audit and Corrective Action processes and schedules

Maintain the Boeing ESCAN for Non Conformances and Corrective Actions

Perform internal audits and maintain Corrective Action Reports

Change Requests release/incorporation/implementation/notification

CRANE INTERPOINT (Aerospace & Electronics)

10201 Willows Road Redmond, WA. 98052 (Jul 28, 1997 to Apr 25, 2008)

Also, short term contract work through Volt at Crane (from May 17, 2008 to Jul, 2008)

Document Control Supervisor/Agile Administrator (April 2006 to Apr 25, 2008)

Supervise Document Control associates and Local Controllers under direction from Quality Management

KPI cell weekly maintenance (Cost/Safety/Delivery/Standard of Work charts/ Excel pivot tables)

Process improvements, employee training, including responsibilities of Document Control Lead

Document Control Lead (October 2004)

Assist Configuration Management with BOMs, EOs, parts updates in ManMan – MRP database

Maintain ISO/Engineering Industry/MIL Specs related materials for the Quality and Engineering Department

Create/maintain external suppliers Agile accounts per ITAR regulations

Create/maintain Agile workflows; new users account for Redmond & Taiwan

Iron Mountain Connect Administrator: retention, archival, storage and destruction of company records

Technical Editor I & II (July 1997 to October 2004)

Edit Power, Medical, Space and Custom controlled documents via ECOs using Agile CM

Create, update, maintain new documents, drawings, internal work instructions from redlines

Conduct projects for updates to Manufacturing Procedures to comply with ISO standards and internal audits

Train local controllers, operators, and engineers on Agile related processes

Store, retrieve, and maintain retention schedule for the documentation-controlled inventory data

Maintain Material Safety Data Sheets Log

MICROSOFT

21919 20th Ave. SE, Bothell, WA. 98021 (August 1994 to July 1997)

Document Control Lead (April 1997 to July 1997)

Perform all document control, ISO/QMS related tasks for the Canyon Park site

Responsible for document creation, release, update, and notification

Centralized Master List maintenance and book updates (18 QMS Manuals, 21 Department’s work instructions)

Maintain daily log of DCN’s (Document Change Notice) including creation, filing and archiving

Document Control Assistant (August 1994 to December 1996) -assisting the Document Control Supervisor (January 1995 to August 1996)

Maintain obsolete documentation, archived disk database, quality records (ie; ECNs, Approved Supplier List)

Support all local controllers managing a high-volume alias

Support the ISO/QMS Forum and Implementation team

Configuration Management Local Controller (August 1994 to August 1996)

Assist the World Wide Configuration Management Department (WWCM) as their Local Controller

Update work instructions & reference materials, master lists, historical files

Document creation from redlines

ECN distribution & filing

Create /manage ECN database for daily use and archival retrieval (Excel spreadsheet)

COURSES & TRAINING

Business Excellence: Change Management, Continuous Improvement, End2End Lean Basics, Performance Management, Process Management, Project Management (03/15 & 16, continuous)

Agile CM PLM User & Admin 8.0 & 9.0 (08/01), 8.5 (05/05), 9.0 (8/06), 9.3.3 (07/14)

ETI Group, ISO9001/AS9100 Internal Auditor Training (05/08)

Nadcap Special processes (AC7108, Rev C: Chemical Processes, auditor’s handbook) (05/08)

Global Bribery & Corruption Awareness (11/07)

Export Controls: Military Products (ITAR) (4/26/07 & 7/5/07)

Export Controls: Commercial Products (BIS) (12/22/06)

Visual Management at the Cell: KPI; Kaizen, 5-S, Standard Work Charts (01/06)

Bureau of Veritas, ISO9001/AS9100 Internal Auditor Certification (11/06)

Lean Yellow Belt Training - OpEx, Six Sigma Overview, DMAIC steps, On-time Delivery (04/04/03)

Application Extender/Ascent Capture - Scanning Software for Traceability (2002)

Malcolm Baldridge National Quality Training (03/02)

Washington Manufacturing Services - Principles of Lean Manufacturing (04/17/00)

EDUCATION

Bellevue Community College – 2000 Bellevue, WA (English, Speech, Algebra, Math)

Lake Washington College – 1999 Kirkland, WA (Psychology, Math)

Renton Technical College – 1992/1994 Renton, WA (Information Processing Specialist Certificate)

Shawnee State University – 1988 Portsmouth, OH (Economics, Sociology, Programming, Math, English)

Cristobal High School – 1987 Coco Solo, Colon, Republic of Panama

VOLUNTEERING

Child Strive – 2015 Lynwood, WA (Cleanup crew)

Provide one day of cleaning services to the building infrastructure

Volunteers of America (Sultan Food Bank) – 2016 Sultan, WA (Driver for 3 grocery stores)

Pickup, delivery and setup of donated food to the Sultan Food bank every Friday morning for 6 mos. Food provided to help the low-income families in the community

Oxbow Farm – 2017 Duvall, WA (Cleanup crew)

Provide one day of cleaning services to the organic farm’s landscape

REFERENCES

Upon request



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