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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Treadway Ave.
Cleveland, OH Street Address
PHONE NUMBER AVAILABLE
EMAIL AVAILABLE
Experience:
PHILIPS (Contract)
Highland Heights, OH, 3/2016 to 9/2016
Quality Engineer, Ship Hold Coordinator
Managed Ship Hold status on CT/AMI medical diagnostic imaging systems: reviewed orders for completeness and conformance with ship hold and regulatory specifications.
Placed orders on ship hold, gathered rework evidence, acted as Primary Reviewer of rework evidence, submitted rework evidence for approval, and removed orders from ship holds to facilitate product release.
Coordinated ship hold efforts with: Product Quality Engineers, Material Review Board, and Global Order Desk and acted as liaison with colleagues at Philips facilities in Haifa, Israel and Suzhou, China.
Maintained and distributed databases of product orders in review process and product orders released.
STERIS CORPORATION, Pinecone Biological Operations
Mentor, OH, 4/2004 to 4/2015
Quality Control Laboratory Technician I, II
Initiated and concluded all incoming QC Lab testing: reviewed and completed Test Requests, entered testing into lab database, created test folders, assigned testing, acted as Primary Reviewer of all test data and results, forwarded completed test documentation to facilitate product release.
Performed product acceptance, stability and validation testing of biological and chemical sterilization indicators and integrators designed for use with ethylene oxide, steam, dry heat and vaporized hydrogen peroxide (VHP) sterilization.
Performed product acceptance, stability and validation testing of biological and chemical indicators for use with STERIS System 1 and STERIS System IE medical instrument sterilization processors.
Facility SDS Administrator. Organized, updated and maintained the facility Safety Data Sheet active and archive binders. Assisted in the transition to all electronic SDS database.
Performed morning warm-ups of ethylene oxide, steam and VHP BIER sterilization test vessels.
Verified micro-pipette calibration, verified scale and balance calibration, performed scheduled cleaning of laboratory rooms. Prepared culturing media and performed growth promotion and sterility testing on media. Tracked inventory and ordered laboratory supplies as needed. Trained laboratory personnel.
Training completed: QSR/cGMP/ISO/MDD annual training, Laboratory Safety and Spill Kit annual training, Dale Carnegie Change Management training, DuPont Safety Training Observation Program (STOP), Toyota LEAN manufacturing training, OSHA Voluntary Protection Program (VPP) training.
DONOHOE DIGITAL LLC
Castle Rock, CO, As Needed 7/2003 to 7/2005
Software Tester, Technical Writer
Participated in the alpha, beta and patch testing of computer game software developed by Donohoe Digital.
Tested software at each stage of development. Reported any bugs or oversights found during testing. Provided feedback on stability, game play, fidelity to original game source and overall functionality of software.
Lead writer of printed player s manual for WAR! Age of Imperialism computer game.
BEN VENUE LABORATORIES Inc.
Quality Assurance Department, Bedford, OH, 8/2000 to 6/2003
Quality Assurance Specialist I (7/2002 to 6/2003)
Reviewed sterilization and lyophilization records to insure compliance with standard operating procedures and current good manufacturing practices.
Worked with the Sterilization / Lyophilization Department to properly document and resolve issues related to sterilization and lyophilization processes.
Reviewed Deviation Reports related to sterilization and lyophilization processes, wrote and presented quality assurance disposition recommendations.
Attended 2 day on-site training seminar: Fundamentals of Lyophilization , presented by Edward Trappler and Anthony Cannon of Lyophilization Technologies Inc.
Conducted, wrote and presented investigations into production issues that exceeded the scope of Deviation Reports.
Extended experience and communication with customers. Hosted conference calls with relevant Ben Venue and customer personnel in order to resolve product issues. Helped answer customer questions during customer audits of Ben Venue facilities.
Quality Assurance Auditor (8/2000 to 7/2002)
Performed daily audits to monitor the manufacturing process of parenteral drugs. Insured compliance with standard operating procedures and current good manufacturing practices.
Insured that FDA and MCA regulations followed.
Reviewed and audited aseptic filling and decontamination operations.
Wrote Auditor s Reports and Red Tag reports.
Limited experience and communication with customers.
Contributed input for improving production and documentation operations.
THE LIMITED; BATH & BODY WORKS
Research and Development Lab, Columbus, OH, 5/2000
Two week temporary assignment as a Laboratory Assistant.
Basic colloid chemistry used to make prototypes of new products.
Introduction to business and corporate culture.
CASE WESTERN RESERVE UNIVERSITY
School of Medicine, Department of Geographic Medicine, Cleveland, OH, 4/98 to 4/99
Research Assistant II
Murine model based research of human onchocercal keratitis / dermatitis, including handling of mice, immunohistochemistry, chemokine assay (ELISA), and cell culture techniques.
Computer based analysis, presentation, and storage of research data.
General lab maintenance, including ordering supplies and keeping inventory.
THE OHIO STATE UNIVERSITY
Department of Zoology, Columbus, OH, 9/96 to 6/97
General Laboratory Assistant
Setup and broke down experiments; including preparing slides and samples.
Maintained and calibrated scientific equipment (microscopes, videoscopes, etc.).
Helped proctor tests.
THE OHIO STATE UNIVERSITY
Department of Zoology, The Ohio Cooperative Fish and Wildlife Research Unit, Columbus, OH, 9/94 to 6/96
Student Programmer
Learned and used Geographic Information Systems (GIS) technology to help create the "Wayne National Forest GIS Database".
Helped compile and analyze data on Cowbird (Molothrus ater) predation of migratory songbirds in the Wayne National Forest.
Attended The Ohio State University's fresh water biological research station: Franz Theodore Stone Laboratory, South Bass Island, OH. Contributed to field and laboratory research.
Provided clerical assistance.
Software / Hardware Experience:
Proficient in Windows and Mac environments: Windows Office Suite, iWork, iLife
SAP, TrackWise, Agile, SharePoint, Windchill PLM, CAMMS for Windows, Prism, SoftMax
Geographic Information Systems, Steam Sterilizers/Autoclaves, Steam/EO/VHP BIER vessels
Education:
The Ohio State University, Columbus, OH. Bachelor of Science - Zoology, June 1997. Magna Cum Laude, Dean s List
Cuyahoga Community College, Cleveland, OH. Associate of Science, June 1993. Summa Cum Laude, Dean s List |
