Customer Service Production Quality Engineer Management |
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Objective: To obtain a position, utilizing the abilities I have developed through my experiences, and training.
Education
DeVry University, Indianapolis, IN.
Bachelor of Science in Technical Management
Member Of: Delta Epsilon Iota Honor Society
Member Of: ASQ
Technical Knowledge
• Beginner level Six Sigma and Kaizen training
• Quality and Production Auditing experience
• SOP and GMP training
• Aseptic and Production Trainer experience • Knowledge of CFR 21, 210 & 211 cGMP.
• Training on Clearance and Release documents
• Beginner level SAP Training
• Experience with FDA document procedures
Professional Experiences
03/2012-Present
Elwood Staffing/Pac Moore “Foods & Pharmaceutical Contract Manufacturing”
Team Lead of Production
• Fill in for Supervisor and delegate regular and temp staff on day by day or weekly schedule to designated work areas.
• Overseeing 10 to 15 Direct Reports, regular and temp staff employees, training them on Spray Dryer and PLC boards and other machinery and Continuous Improvements.
• Set-up and basic troubleshooting problem solving techniques.
• Assist with SOP revisions and job description aids for employees to have a better understanding on the processes, and how the jobs are to be set –up and performed.
• Knowledgeable in all aspects of operating the heating equipment and controls (electrical, mechanical and hydraulic) required to convert liquid food products into powders.
• Monitor equipment operation, gauges, and panel lights to detect deviations from standards & adjust gauges, PLC’s, and all other operational controls.
• Record gauge readings, test results, and shift production.
• Transport materials and products to and from work areas, manually, or by pallet jacks and forklifts and pulling quality samples.
• Adjust controls in order to activate, set and regulate equipment according to specifications.
• Weigh or measure specified amounts of ingredients or materials for processing, using devices such as scales.
• Clean, lubricate and maintain a sanitary condition of all processing equipment, utilizing chemicals, automatic and manual cleaning equipment.
• Follow all S.O.P.’s (Standard Operation Procedures).
• Comply with plant policies regarding employee safety, food safety, process efficiencies, and product quality. Follow up with monthly audits in the different areas to make sure that workers are keeping areas up to code with OSHA, and FDA, and HACCP, and GMP’s that all processes are being performed correctly.
• Utilizing Lean, Six Sigma and Kaizen …
03/06 – 03/2012
SigmaTau Pharmasource, Indianapolis, IN.
Lead Fill Operator/Production Technician
• Fill in for Supervisor and delegate regular and temp staff on day by day or weekly schedule to designated work areas.
• Fill and Production Operator, working in clean room area, overseeing 30 to 80 Direct Reports, regular and temp staff employees, training them on Aseptic filling machine processes, and set-up and basic troubleshooting problem solving techniques.
• Training employees on equipment prep, Vial wash, set-up, troubleshooting, staging different recipe vial sizes and working with Autoclave and PLC boards.
• Assist with SOP revisions and job description aids for employees to have a better understanding on the processes, and how the jobs are to be set –up and performed.
• Filling out and inspecting batch records to make sure that they comply with FDA and MHRA policy standards and regulations.
• Follow up with employees on Stocking Areas with Personal Protective Equipment (PPE) and supplies, vital for the process.
• Follow up with monthly audits in the different areas to make sure that workers are keeping areas up to code with OSHA, and FDA, MHRA and that all processes are being performed correctly.
• Reviewing batch records for QA Compliance and Quality Inspectors.
• Reviewing clearance and release forms to make sure that the rooms and components are all in compliance, and within the proper expiration dates.
• Beginner level Six Sigma and Kaizen philosophy training...
08/04-01/06
Sr. Material Production Technician
Volt / Eli Lilly
Indianapolis, IN.
• Manufacturing Raw materials, Intermediates and API (Active Pharmaceutical Ingredients.
• Sampling and Dispensing level I, II, III materials and pulling Analytical samples.
• Staging and weighing materials for processing.
• Sampling for Engineers, Lab technicians.
• Packaging and shipping materials to local clients and Domestic and International areas.
• Time Management and some Managing involved
• Training workers on aseptic gowning and aseptic techniques and process
• Inventory and Stocking and cleaning Chemical Solvent Room
• GMP and SOP trained, Hazard material trained, Bullard hood and PPE (Personal Protective Equipment) trained and Forklift trained.
• Performing reconciliations of material and components, and reviewing batch records for errors.
01/02-06/04
Manufacture Production Supervisor
Xanodyne Pharmaceuticals Corporation
Indianapolis, IN.
• Supervising, and going over daily assignments, as well as preparing team for daily operations.
• Training other workers on procedures. Responsible for activities required for successful operation of assigned production area, which operates on a 5day per week schedule. These activities include
Ensuring batch production activities follow all documentation and standard operating procedures
-Setting process execution and operator work assignment schedules
• Responsible for cGMP compliance, ensuring that all production equipment is properly validated and production processes meet quality standards.
• Authors and revises standard operating procedures, batch records, non-conformance events, change controls and technical reports.
• Subject matter expert in area assigned and train operators in all procedures and batch records pertaining to assigned production area.
• Provides production review of completed batch documentation for cGMP compliance and accuracy.
• Addresses all issues raised during review.
• Along with safety and maintenance problems, communicates status of operations in a timely manner to management.
• Making minor repairs and troubleshooting.
• Performing quality inspections on tablets and other pharmaceutical drugs.
• Weighing products and processing, filling out batch records and reviewing for errors and reconciliation of material and components.
• Dispensing, Sampling, and packaging and shipping.
03/00-02/02
Digital Field Engineer
HPS Office Systems
Indianapolis, IN.
• Managing, Customer service, talking to customers in person and over the phone to troubleshoot issues and concerns dealing with computer hardware and software issues and copier issues.
• Troubleshooting and repairing Toshiba, Savin, and Riso copiers, lasers and inkjet printers.
• Computer modifications, troubleshooting, and repairing minor networking problems.
• Reviewing printer charts for best quality alignment.
*References Available upon Request
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