Thomas M. Neidert

**** ******** ******

Lakewood, Ohio 44107

216-***-****

acypow@r.postjobfree.com

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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