Shelly Page Resume 2015
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Shelly Page has over 15 years of experience in quality assurance and quality control roles in the biomedical industry. She has worked at several medical device and biotech companies, including Biovest International, Vascular Solutions, and Eniva Corporation. At these companies, she performed tasks such as environmental monitoring, inspection of materials and products, documentation of quality events, and ensuring compliance with FDA regulations. Currently, she is pursuing further education in quality systems at Anoka Ramsey Community College while maintaining her experience in the field.
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- 1. SHELLY J. PAGE 3501-170TH Lane Northwest, Andover, Minnesota 55304 spage2689@msn.com Mobile 763.350.2689 _____________________________________________________________________________ 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 DCOs, MRRs 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.
- 2. Shelly Page Page 2 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 companys 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 Bachelors Degree with Honors Graduate (Summa Cum Laude) Carlson Certificate of Quality