1. spage2689@msn.com
Mobile 763.350.2689
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EDUCATION
Quality Systems for Biomedical Industry, in progress
Anoka Ramsey Community College, Coon Rapids, MN
Bachelors Degree in Science- Applied Business Management, 2011
Dunwoody College of Technology, Minneapolis, MN
Associates Degree in Science- Biomedical Research Technologist, 2008
Anoka Ramsey Community College, Coon Rapids, MN
PROFESSIONAL EXPERIENCE
Biovest International, Coon Rapids, MN
QC Inspector/Environmental Monitoring Technician, 22SEP14-30MAR15
• Preform clean room and Cell Culture Laboratory Environmental Monitoring per cGMP guidelines.
• Dynamic member of a team preparing for a European Union Certification for a cancer vaccine.
• Experienced with Pharma documentation systems, validation protocol and regulatory inspections.
• Initiate DCO’s, MRR’s and Quality Events (Deviations) when applicable to improve specifications
and procedures, following FDA regulations.
• Knowledge of FDA Regulations 21 CFR 820, EU GMP, ISO 13485, 15378, 14971, 9001.
• Aseptic sampling, Incoming Biological Material Inspector.
• Verifying that only Approved materials are incorporated into the cGMP purification of cell culture
lines and vaccine production.
Vascular Solutions Incorporated, Maple Grove, MN
QA/QC Inspector I, July 2011-19SEP14
• Efficiently preform inspections per IP, measurement systems analysis, calibration and metrology.
• Read prints, understand tolerances, dimensions, destructive and non-destructive testing.
• Trend inspection results, investigation duties and manufacturing process auditing.
• Document return authorizations, processed complaints and product traceability.
• Managed and investigated field actions; such as DER notifications.
• Preform and/or analyze microbiological and bio burden sterility testing.
• Train new inspectors on techniques and methods (FDA, GMP and ISO13485).
• Preform functional testing, calibration and certification inspections of medical grade laser console
units.
• Follow FDA Regulations.
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Eniva Corporation, Anoka, MN
Laboratory Technician, (Contract Position) January 2011-July 2011
• Provided assistance to QA, Micro and R&D Departments.
• Preformed microbiology stock and product sterility cultures.
• Sample preparation and testing for HPLC and ICP instruments.
• Compliance with company’s GLP, GMP and SOP requirements.
Medtronic Physiological Research Laboratories Inc., Coon Rapids, MN
Regulatory Compliance Coordinator (Independent Consultant), May 2008-August 2008
• Reviewed GLP Study Protocols and FDA Final Reports for QA compliance.
• Evaluated various departments own unique compliance to Standard Operating Procedures.
• Collaborated with research team members to prepare for study initiation.
• Built a degree of excellence by maintaining compliance to all quality requirements while following
FDA regulations.
Anoka-Ramsey Community College, Coon Rapids, MN
Laboratory Assistant (Biology Department), March 2005- December 2008
• Performed microbiology culture transfers, electrophoresis gel/media and reagent preparation.
Anoka-Ramsey Community College, Coon Rapids, MN
Laboratory Assistant (Nursing Department), March 2005-December 2008
• Duties included monitoring and security of the lab, weekly case study preparation.
Shakopee Valley Printing, Shakopee, MN
Licensed Commercial Driver, 1999-2004
• Recognized for outstanding work ethic due to job performance and perfect attendance.
Wolff Laboratories, Bloomington, MN
Laboratory Technician CVT, 1998-1999
• Performed diagnostic testing and application, interpreting and reporting results.
Plymouth Heights Pet Hospital, Plymouth, MN
Lead Surgery Technician CVT, 1987-1997
• Developed and implemented Veterinary Technician and intern training protocol.
Metropolitan Veterinary Referral Services, Eden Prairie, MN
Intensive Care Unit Nurse CVT, 1995-1997
• Provided specialized care and treatment for high-risk critically ill patients.
HONORS
Bachelor’s Degree with Honors Graduate (Summa Cum Laude)
Carlson Certificate of Quality
Multi scholarship recipient
Dean’s List