Quality Assurance Technician
Resume:
Thomas M. Neidert
Lakewood, Ohio 44107
********@*********.***
Education and Training
B.S. in Engineering, Wright State University, Major in Human Factors Engineering, Minor in Psychology,
Certified Lyophilization Technician, Certified Palltronic Filter Tester Technician
Primary Experience
October 2013 to May 2015: Aerotek Inc., Quality Engineer (Contractor)
Assigned to Invacare Inc.
Processing complaints in the Complaint Handling Unit (CHU) Group Two
DHR and pertinent documentation review
MDR filing, Canadian and USA
April 2009 to January 2013: Ben Venue Labs, Production Technician/Trainer
Responsible for the daily operation of Sterilizers and Freeze Driers. Responsible for the training of new and current employees in the operation of the Sterilizers.
Support the Validations Department in the qualification of Sterilizers and Freeze Driers
Team member of MST for developmental studies on the Freeze Driers and Sterilizers
Team member of the On Job Training Module team
Team member if Filter Integrity Testing team
Developed training modules for the operation of Hot Air Ovens, Autoclaves, Palltronic Filter Tester and Barriquand
Presented Reach Award by MST for outstanding support work on multiple projects
Presented Reach Award by HR for culture change awareness
January 2008 to December 2008: Ben Venue Labs, Quality Systems Specialist
Performed root cause analysis and CAPA generation for the disposition investigations and deviations
September 2005 to December 2008: Ben Venue Labs, Lyophilization/Sterilization Technician
Performed daily monitoring of active lyophilizers
Prepared lyophilizers for scheduled manufacturing operations
Operated the Autoclaves, Hot Air Ovens and Barriquands
Team member of Quality Day Committee
Team member of cGMP Training Committee
Team member of the Opportunity for Improvement Committee
June 2003 to September 2005: Ben Venue Labs, Quality Assurance Specialist I - Lyophilization
Reviewed and approved of manufacturing records for lyophilized products
Executed root cause analysis and CAPA generation for investigations and deviations pertaining to lyophilization cycles and processes.
Revision and creation of SOP’s
member of CAT 38 Team
Consult and respond to client inquiries concerning lyophilized products and processes
Train current and new employees in lyophilization record review and processes
Member of the International Society of Lyophilization - Freeze Drying.
June 2002 to June 2003: Ben Venue Labs, Quality Assurance Auditor
Audited the daily aseptic filling operations
Performed departmental internal audits
Investigated and disposition of deviations
Review and revision of SOP’s
Team member in Quality Improvement Program
July 1999 to March 2002: Parsons. Cleveland, Ohio. Equipment Room Manager/Lab Coordinator
Performed routine maintenance, tracking and purchase of all field equipment
Inventory tracking and materials acquisition
Train field technicians in proper use and care of field equipment
Coordinated daily operations between environmental laboratories and company clients
Negotiated purchase contracts with vendors
Shipping and receiving operations
August 1998 to May 1999. EC Laboratories. Middleburg Heights, Ohio. Laboratory Technician
Performed EPA/FDA regulated tests on soil and water samples.
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