Work History

Work History
Mar 2011 - Present

QA Specialist

Oligos Etc. Inc.

Temporary position (current)

  • Managing change control and records system, company-wide
  • Creating, revising and routing technical documents for approval
  • Creating customized final product specifications for individual customer orders
  • Assigning part numbers for new products, raw materials and in process parts
Aug 2010 - Dec 2010

Document Control Specialist, Quality Assurance

Yoh Employment Services

Temporary Position at Bayer Health Care Diabetes Care at Wilsonville Site

  • Edited and released material specifications and other technical documents
  • Routed specification and validation documents for approval
  • Organized approval meetings and recorded minutes
  • Assigned part numbers
  • Filed and organized both electronic and paper records
Oct 2009 - Aug 2010

Document Control Specialist, Manufacturing Service and Technology

Aerotek

Temporary Position at Genentech Hillsboro Fill/Finish Site

  • Tracked and managed validation system documents for MSAT group to complete review/approval processes
  • Assisted engineerings in preparing documents for approval process
  • Prepare documents for storage as records
  • Ordered office supplies for MSAT group
Dec 2002 - Dec 2008

Document Control Coordinator, Quality Assurance

HemCon Medical Technologies, Inc.

Regular Employee, lay off/lack of work

  • Managed Controlled Document System per regulatory requirements, company policies and procedures
  • Administered and validated Q-Pulse databases for management of Quality System data
  • Development, Editing and Revision of technical documents including, Standard Operation Procedures, Specifications, Work Instructions, Qualification Protocols, Forms, etc.
  • Assigned part names and numbers for new products, existing products with system changes, in process materials, raw materials and lab supplies
  • Provided new employee training for all employees and ongoing training as needed for system changes and upgrades
  • Participated in interdepartmental/multi-function teams as a Quality representative to provide information on document system impact and other Quality department concerns
  • Assisted internal customers with access to the document system data and functions
  • Provided data reports, as needed to management for Quality System improvement programs
  • Designed, implemented and managed complex and extensive record systems, providing copying, scanning, archiving and other administrative services to internal customers
Apr 2001 - Mar 2002

Data Management Specialist, Clinical Trials

OraSure Technologies, Inc.

Regular Employee, lay off/lack of work

  • Development, Editing and Revision of technical documents including, Standard Operation Tasks and Procedures, Work Instructions, Qualifications, Case Reports, Data Capture Forms, etc.
  • Database Creation, Modification, Data Entry, Accountability, Summary and Analysis
  • Assisted others and working with a team to increase compliance with FDA, CBER and ISO guidelines and requirements
  • Created and implemented expensive filing systems and organizational procedures
  • Focused on multiple priorities and product deadlines while maintaining flexibility and a professional demeanor
  • Collected specimens from Community Volunteers for research and development of medical diagnostic devices
  • Signed and approved documents as required by position
  • Communicated effectively with both internal customers and external researchers and vendors
  • Entered clinical data into databases and provided auditing of other data entry
  • Developed and performed Performance Qualifications on databases used for clinical data
  • Provided data summaries and information on clinical data to management, as needed
Jul 2000 - Apr 2001

Document Control Assistant, Quality Assurance

OraSure Technologies, Inc

Regular Employee after Temp to Hire, internal change after position was targeted for lay off

  • Assisted internal customers with access to the document system data and functions
  • Edited documents for compliance with company and regulatory compliance
  • Database Creation, Modification, Data Entry, Accountability, Summary and Analysis
  • Assisted others and working with a team to increase compliance with FDA, CBER and ISO guidelines and requirements
  • Created and implemented expensive filing systems and organizational procedures
  • Signed and approved documents as required by position
  • Focused on multiple priorities and product deadlines while maintaining flexibility and a professional demeanor
Apr 1999 - May 2000

Director

Comunidad Child Care Center
  • Opened and operated a non-profit child care center for infants and toddlers, affiliated with Mennonite Church North America
  • Hired, trained and managed staff
  • Planned and prepared meals, as needed
  • Completed all purchasing tasks
  • Processed payroll and all recordkeeping associated with employees and enrolled children
  • Interacted with Childcare Licensing to complete licensing process

Education

Education
Sep 1994 - Mar 1996

B.A., with Honors

Portland State University

Course Work Included:Statistical analysis, experimental design and technical writing for publication

Aug 1991 - Jun 1993

A.A.

Hesston College

Coursework included Early Childhood Education and Developmental Psychology

Work Experience completed at continuous care senior facility

Skills

Skills

Adobe Acrobat

Adobe Acrobat and I are old friends. I've completed specialized training in creating forms, using fields that update and other advanced tasks.

Typing/Data Entry

My last typing test in January 2011 rated my speed at 68 wpm. The test was administered by AppleOne.

Q-Pulse Quality System software

I completed a validation and company wide implementation of Q-Pulse software when I was at HemCon and know the system inside and out.

MS Word

I am a MS Word Rockstar. I can do just about anything MS Word is capable of. My formatting skills are honed and nearly an unconscious reflex.