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Work experience

Mar 2011Present

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 2010Dec 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 2009Aug 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 2002Dec 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 2001Mar 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 2000Apr 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 1999May 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

Sep 1994Mar 1996

B.A., with Honors

Portland State University

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

Aug 1991Jun 1993

A.A.

Hesston College

Coursework included Early Childhood Education and Developmental Psychology

Work Experience completed at continuous care senior facility

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.

References

Anna Mueller

Gina Hansen is an experienced Quality professional that I can recommend highly. Through her work as a Quality Assurance / Document Control specialist, she has gained an impressive understanding of medical device and pharmaceutical operations, including requirements for quality system, validation, and design control documentation. She understands the need for accurate and complete documentation in the highly regulated world of medical device and pharmaceutical industries.  I have worked with Gina as a colleague of hers in the Quality department at two companies in the last 10 years, and I have always been impressed with her attention to detail, her ability to learn quickly and how she consistently met her goals and got the job done.

Mihai Resch

Gina demonstrated excellent skills within the Quality field, being a key factor in developing and implementing a compliant Quality System. Beside the expertise in Document Control she brings with her a great personality and inspiring attitude. She is a must have for any organization aiming for quality and improvement. 

Mike Williams

Gina was a diligent employee who was always willing to make sure that her work was completed.  She pays great attention to details and was able to handle shifting priorities and rapid change with aplomb.  I am available to discuss her talents and abilities more fully should you have additional questions.  Gina was a valuable member of the HemCon team.

Summary

·10+ years of experience managing a Change System and/or data management

·Proven ability to coordinate system changes with multiple departments throughout an organization

·Strong and varied communication skills, written and verbal, and advanced organizational skills

·Proven talent for working both independently and with a team

·An aptitude for problem solving and determining new solutions to problems, before they affect a process

·Solid understanding of, and experience with, FDA, ISO CE Mark and other regulations

·Flexibility with working hours, settings and environments required to meet company needs and goals

·Technical Writing experience in regulated/scientific industry, SOPs, specifications, forms

Volunteer: US Dept. of Veterans Affairs, Portland VA Center

2009

Clerical Assistant with Finance Department, assisted VA Center employees with processing statements and receipts

Volunteer: Dress for Success Oregon

Volunteer: Soldiers Angels

2007 - present

Angel, supporting deployed soldiers with letters and packages

Contributor to Blankets of Belief and Blankets of Hope projects by handmaking comforters for soldiers and veterans

 http://www.soldiersangels.org/