•Responsible for managing CAPA program and associated CAPA's.o Facilitate weekly CAPA Review Board (CRB) meetings.o Review all CAPA 4-panel updates weeklyo Track CAPA metrics related to extensions, awareness response, on-time closure, etc.o Review all phase documents/addendums/extensions and attend all Tech Review meetings related to CAPAs.o SME for all CAPA phases/procedures that include initiation/investigation/solution development and verification of effectiveness. • Responsible for owning my own CAPA phases.• Support nonconformance program and the associated nonconformances.Other Positions Held: Quality Engineer - Product Quality Assurance July 2020 - October 2021•Responsible for the creation, investigation and managing nonconformances, as well as associated ship holds and product dispositions. •Used statistical techniques to trend quality performance, identify quality problems and help improve internal efficiency. Supply quality metrics as requested.•Acted as primary reviewer for back room audit/inspections including FDA.•Product Quality Assurance team member of product quality issues "Tiger" or Task Force Team.•Assisted with compilation and analysis of product quality metrics for presentation to Global and business unit leadership. Utilized basic statistical techniques to identify rates, changes in trends or estimated occurrences based on bench and field data.Quality Engineer - Customer Advocate Team Nov 2018 - July 2020•Responsible for analyzing product complaints and samples. Confirms complaint and determines root cause where possible.•Notifies manufacturing site of any potential manufacturing issue as a result of a reported complaint. Initiates non-conformances when required.•Interfaces with a variety of internal and external customers including: Manufacturing, Marketing, R&D, and Regulatory.•Works closely with the manufacturing sites to determine the product inspection criteria and correct test specifications required.

• Responsible for all Process and Quality activities at two Commercial Manufacturing Organizations (CMOs) and their Raw Material Suppliers – One Upstream who created the Assay Cards and one Downstream who created the Finished Product.• Accountable for Tech Transfer of a R&D process in North Carolina to a fully Manufacturing Process at CMO in Minnesota.• Experienced in reducing operations cost through process improvements at CMOs – Example, reduced cost of Assay Cards from $1.07 to $0.63 within the first few months. A savings of ~ $40,000 a month when at full production.• Responsible for the creation and implantation of all process related documentations including but not limited to Manufacturing, Material Specification, Risk Analysis, and Test Methods. Experienced in setting up a Quality like System that included a Document Change Control and Training Policy, along with Risk Analysis based Sample Plans and Supplier Approval procedures – Something that didn’t exist prior.

Process Development – Team Lead 11/2017 to 03/2018• Team leader for manufacturing associates and Process related functions/SOPs• Responsible for creating and tracking manufacturing metrics/paratos• Responsible identifying and working on Process Improvements• Provides assistance with CMO on equipment and process troubleshootingSenior Associate Scientist -Project Leader of Product Development 08/2015 to 10/2017•Experience writing protocols, executing them and completing test reports. Examples include: o Characterizations o Design Verifications o Variety of notebook studies• Project Management Experience: o Liaison between product testing facilities and Micell o Set and Update Project Timelines/Budgets – Relay timelines/budgets to necessary personal o Experience with taking product from Feasibility through Product Launch o Review testing facilities protocols/test reports o Investigate/solve problems or issues with testing or testing results o Review/Work up data o Use data collected to drive future projects/marketing toolsOther Positions HeldProcess Development Associate II 01/2013 to 07/2015Process Development Associate I 01/2012 to 12/2012Manufacturing Tech 05/2011 to 12/2011

Responsible for Drug Testing in Extractions LabAccountable for following and adhering to standard operating procedures and chain of custody formsExperience working within a clean room environmentResponsible for making reagents and handling chemicalsTrained to properly handle and deal with hazards materials