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Karen Campbell
613 324 9109
Objective
To apply and enhance my experience
in a position where teamwork and
mentorship will drive the
advancement of a company’s service
standards and processes.
Skills
Development and implementation of
quality processes while training teams.
Standard Operating Procedure (SOP)
creation and maintenance.
Development of visual management
systems as Metric Boards.
Data analysis of metrics included
Quality Notifications and Internal
Device Failures for root cause
analysis to Corrective Action.
Example: Leader for team to solve
Product batch failure:
Reduced failures from 10 batches
per month to zero batches per month
in 6 weeks.
Qualified Practical Process
Improvement (PPI –Lean Enterprise)
Facilitator
and Process Manager
Internal ISO Auditor (13485:2003)
Medical Laboratory Technologist
EXPERIENCE
QUALITY ASSURANCE MANAGER
THERMOFISHER
SCIENTIFIC
May 2003 to May 2016
Oversaw the team members for the Quality Control, Technical Support and
Regulatory departments while managing the processes as they
inter-related with the organization locally and globally.
Managed and assessed team member’s Professional Management
Development portfolios (PMD) to include annual goal setting and
evaluation.
Developed others through coaching and training.
Led and participated in global conference meetings relating to
Environmental Monitoring, Cleanroom operations, Quality Notification
Investigations and Instrumentation Services.
MEDICAL LABORATORY TECHNOLOGIST
CHILDREN’S HOSPITAL OF EASTERN ONTARIO, BRANTFORD
GENERAL HOSPITAL, TORONTO HOSPITAL FOR SICK
CHILDREN
Sept 1986 –May 2003
Experienced Medical Laboratory Technologist in Biochemistry,
Hematology, Microbiology and Transfusion Science. Worked in large
Clinical laboratories
and small industrial facilities.
Laboratory Skills include manual microbiology techniques, Polymerase
Chain Reaction (PCR ) and Instrumentation
2
Karen Campbell
613 324 9109
Further Skills
Responsible for Design and
Development of new products.
Supported submissions for Class 3
products to Health Canada
Class 2 Biosafety Lab setup and
Primary contact as Bio-Safety
Officer
Conflict Management and
Resolution
EDUCATION
DEVELOPING EMERGING LEADERS PROGRAM /2012-2013
ThermoFisher Scientific Corporate Training
PRACTICAL PROCESS IMPROVEMENT (PPI) FACILITATOR &
PROCESS MANAGER CERTIFICATION/2010-2011
ThermoFisher Scientific Corporate Training
GOOD LABORATORY PRACTICES-FDA GUIDELINES/2008
Bio Talent Canada
INTERNAL AUDITOR ISO 13485:2003 MEDICAL DEVICES, ISO
9001:2000 CERTIFICATION/2007
Business Resource Centre
COMPETENCE OF TESTING AND CALIBRATION
LABORATORIES 17025:2005 COURSE/2007
Business Resource Centre
MEDICAL LABORATORY TECHNOLOGY DIPLOMA/1989
Mohawk College, Hamilton Ontario
BACHELOR OF ARTS (HONORS) PSYCHOLOGY/1986
University of Western Ontario
ADDITIONAL LEADERSHIP EXPERIENCE
TECHNICAL SUPPORT & CUSTOMER SERVICE
APPRECIATION WEEK:
Coordinator
SOCIAL COMMITTEE THERMOFISHER SCIENTIFIC:
Executive Team Member
