Over 18 years' experience in a manufacturing with 14 years in a federally regulated setting, and 7 years in quality assurance & regulatory affairs. My work experience also includes 4 years in sales and 2 years in chemical process engineering. My goals are to bring structure and creative solutions to businesses in a cost efficient manner and develop and educate others.
Over 18 years' experience in a manufacturing with 14 years in a federally regulated setting, and 7 years in quality assurance & regulatory affairs. Work experience also includes 4 years in sales and 2 years in chemical process engineering. Goals are to bring structure and creative solutions to businesses in a cost efficient manner and develop and educate others.
• Key person in developing quality systems to meet federal regulations and corporate business goals
• Developed quality investigation program; highly proficient in quality investigations, root cause analysis, and CAPA projects
• Developed batch production records and manufacturing specifications for over 300 herbal products with complex, multi-process operations; reduced BPR review times by 50%
• Developed process with Operations, QC, and Accounting for federally regulated ethanol reporting to ensure compliance and meet corporate business goals; selected for project due to complex manufacturing process; responsible for over $1M in excise tax refunds annually
• Often selected by senior management to participate in company-wide projects for complex technical topics; consulted for trouble shooting in various capacities
• Authored and reviewed SOPs, technical papers, and proposals
• Trained personnel of all levels on FDA & ethanol regulatory requirements, quality assurance best practices, company procedures, and leadership topics
• Successfully managed sales division for bulk, contract manufactured, and private label projects
• Participated in regulatory and customer audits.
Microsoft Applications/Filemaker Pro/Sage/ERP systems/Adobe
Microsoft Applications/Filemaker Pro/Sage/ERP systems
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