Accomplished in working with quality control and manufacturing in a FDA compliant pharmaceutical environment. I have a proven track record at Forest Pharmaceuticals, adept in compliance monitoring and enhancing operational efficiencies. Expertise in quality assessment and technical writing and troubleshooting, coupled with strong teamwork and collaboration skills. Successfully led quality assurance efforts, achieving significant improvements in packaging integrity and regulatory compliance.
Overview
14
14
years of professional experience
Work History
Packaging Stability Specialist
Forest Pharmaceuticals
Cincinnati, OH
12.2009 - 02.2011
Implemented detailed assessments ensuring regulatory compliance with FDA packaging standards.
Conducted tests on packaging closures, including blister and bottle types, following standard procedures.
Maintained packaging integrity with compliance to strict quality protocols.
Followed all company policies and procedures to deliver quality work.
Led quality assurance efforts, maintaining high standards for all products and services.
Collaborated with cross-functional teams to achieve project goals on time and within budget.
Packaging Supervisor
Forest Pharmaceuticals Namenda and Lexapro
Cincinnati, OH
12.2002 - 12.2009
Oversaw manual and automated packaging activities.
Collaborated with quality assurance team to identify and rectify packaging discrepancies.
Developed, implemented, and enhanced new standard operating procedures.
Conducted troubleshooting to determine root cause to resolve problems.
Assisted with quality and production process improvements to support new packaging initiatives.
Oversaw incoming packaging products and monitored quality of outgoing products to comply with FDA.
Performed packaging tasks alongside team to demonstrate proper methods according to standard operating procedures.
Led improvement initiatives to advance operational efficiencies to decrease waste and increase output.
Trained employees on standard operating procedures and new policies.
Trained new employees on company protocols, safety procedures, and equipment operation, increasing overall team productivity.
Lean Manufacturing Engineer
Cincinnati Machine
Cincinnati, OH
02.1997 - 11.2002
Resolved technical concerns to ensure adherence to internal standards.
Established standard practices to minimize process variability.
Achieved efficient workplace organization through 5S methodology.
Utilized time mapping for optimizing workflows and minimizing deficiencies.
Examined manufacturing data to uncover patterns and optimize workflow.
Education
Bachelor Of Science In Engineering Management - Manufacturing Engineering
Miami University
Oxford, OH
05.2000
Skills
Documentation management
Technical communication
Quality assessment
Technical troubleshooting
Continuous improvement
Compliance monitoring
Workflow automation
Teamwork and collaboration
Organizational skills
Written communication
Project planning
Process improvement
Timeline
Packaging Stability Specialist
Forest Pharmaceuticals
12.2009 - 02.2011
Packaging Supervisor
Forest Pharmaceuticals Namenda and Lexapro
12.2002 - 12.2009
Lean Manufacturing Engineer
Cincinnati Machine
02.1997 - 11.2002
Bachelor Of Science In Engineering Management - Manufacturing Engineering