Experience

US WorldMeds

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manager, Quality Management Systems

  • Jun 2023 - Present



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Regulatory Compliance

  • Feb 2022 - Jun 2023

  - Managed a team of eight across various responsibilities: Supplier Quality Assurance, state licensing, drug listing, submissions support, external audits, and internal audits • Reviewed supplier questionnaires, supplier risk assessments, and supplier complaints. o Supported risk assessments for supplier issues and notifications • Reviewed and approved external and internal audit reports • Supported collection and review of data and documents to support client submissions- Initiated weekly Gemba walks to monitor and improve overall site inspection readiness- Responsible for the presentation of regulatory compliance-associated metrics for Quality Management Review board meetings- Hosted regulatory body inspections, including an inspection by the FDA, and assisted with development of inspection responses- Supported site as a quality representative in cross-functional discussions to ensure compliance to regulations, site and corporate procedures, and industry standards Show less

• Senior Regulatory Compliance Specialist

  • Feb 2021 - Apr 2022

  - Managed the External Audit program • Managed external audit calendar and both external and internal communication regarding the schedule • Led audit preparation activities • Lead host for 30+ external audits, including those for clients and certification bodies • Developed audit response reports with clear, concise verbiage describing response and CAPA plans- Supported and participated in internal audits- Monitored progress and reviewed Quality System (TrackWise) records for accuracy and timely completion- Implemented tracking mechanisms for both TrackWise records and audits- Completed regulatory impact assessments for change controls across multiple areas, including equipment, facility changes, new materials, etc. Show less

• Senior Project Engineer

  • Apr 2019 - Jun 2021

  Completed procurement, installation, and validation of new Packaging and Serialization technologies • Developed project plans to optimize resources and allocated to support milestone achievements• Identified, analyzed, and mitigated risks to prohibit potential delays to project completion• Monitored project progress and enforced adherence to budget, timeline, and quality standards to achieve projected milestones• Created and delivered weekly project status reports and followed-up with project owners and stakeholders on pending action items• Implemented new processes and procedures to manufacture and maintain quality control of packaging products• Continued site-wide technical support for on-boarding of new customers, including change parts assessment, recipe and process development, and packaging component design Show less

• Process Engineer

  • Sep 2013 - Apr 2019

  Process Engineer – Capital Projects (May 2017 - April 2019)• Managing procurement, installation, & CnQ for new GPCG Pro 120• Manage procurement, installation, & CnQ for new equipment needed for new products • Deviation Investigation, Root Cause Analysis, and CAPAs• Deviation Investigation Training and Assistance for Engineering teamProcess Engineer – Fluid Bed Area (March 2015 - May 2015)• Managed Equipment Reliability for (9) Fluid Beds• Assisted with Equipment and Process Troubleshooting• Recipe Development for Fluid Bed processes• Technical Support in the Fluid Bed Area for Product Development and Manufacturing Science & Technology teams• Led Fluid Bed Process Team with a focus on Process Improvement for the Fluid Bed Area• Managed projects to repair and improve equipment• Deviation Investigation, Root Cause Analysis, and CAPAsProcess Engineer – Project Expansion (September 2013 - March 2015)• Developed Process Parameter database and Process Flow Diagrams for various products manufactured in the facility. • Commissioning of Pharmaceutical manufacturing equipment (High-Shear Granulator, Fluid Bed Dryer). • Equipment Delivery (Fluid Bed Dryer). • Leader of Green Belt Project to Simplify and Improve current manufacturing batch records. • Procured new Fire Alarm System• Project Management: Modifying Raw Material Sampling Suites, Laboratory Casework, Lab Offices Show less

• Contract Project Expansion Engineer

  • Jun 2013 - Sep 2013

  • Managed the design and procurement of laboratory casework. Led a cross-functional team to make sure user needs were met and the project stayed under budget. • Participated in Design & Build discussions and planning for an expanded facility



University of Kentucky

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Research Assistant

  • May 2012 - Aug 2012

  Research on lipid-based drug delivery systems. Completed analytical lab work, including dissolution studies with simulated intestinal fluid, and HPLC and DSC analysis. Research on lipid-based drug delivery systems. Completed analytical lab work, including dissolution studies with simulated intestinal fluid, and HPLC and DSC analysis.