Experience

MYCO Medical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Supplier Quality Manager

  • Mar 2023 - Present



Avioq

• United States
• Biotechnology Research
• 1 - 100 Employee

• Senior Quality Assurance Specialist

  • Dec 2021 - Apr 2023

  RTP Experienced auditor who successfully revitalized and managed internal and supplier audit programs. Leveraged regulatory knowledge and analytical mindset to lead ISO 14971:2019 transition activities. Hosted multiple external audits in conjunction with QA Director. Utilized strong organizational skills and Excel knowledge to maintain the Quality Management System.



Medicago

• Canada
• Biotechnology Research
• 200 - 300 Employee

• Industrial Process Specialist II

  • Nov 2018 - Dec 2021

  Raleigh-Durham, North Carolina Area Daily responsibilities include: Operation, Testing, and Cleaning of Tangential Flow Filtration Systems and Chromatography Skids; Preparation and Use of Autoclave; Preparation of CIP Solutions; Bulk Drug Substance Filtration and Packaging; Daily Room Cleanings; Filter and Membrane Integrity Testing; Aseptic Sampling; pH, Conductivity, and Turbidity Probe Calibration; Use of Laboratory Information Management Systems (LIMS) Authoring, Revising, and Formatting of Master Production Records… Show more Daily responsibilities include: Operation, Testing, and Cleaning of Tangential Flow Filtration Systems and Chromatography Skids; Preparation and Use of Autoclave; Preparation of CIP Solutions; Bulk Drug Substance Filtration and Packaging; Daily Room Cleanings; Filter and Membrane Integrity Testing; Aseptic Sampling; pH, Conductivity, and Turbidity Probe Calibration; Use of Laboratory Information Management Systems (LIMS) Authoring, Revising, and Formatting of Master Production Records, SOP’s, and associated forms; perform Training Evaluation for finalized documents from other departments; Owner of Quality Events Change Controls, Corrective and Preventive Actions, and Deviations Authored Validation Protocol for Riboflavin Spray Ball Testing Validation and successfully performed testing Assisted in developing and performing area walkthrough program to ensure Inspection Readiness Participated in PAI audits in a backroom capacity Perform weekly cycle count of production materials consumed Show less



CSL

• Australia
• Biotechnology Research
• 700 & Above Employee

• Manufacturing Associate

  • Dec 2016 - Nov 2018

  Holly Springs Experienced aseptic operator, familiar with aseptic technique, and clean room behavior. Utilized aseptic and cell culture techniques to maintain an animal cell line and virus seed stock for the development of the influenza vaccine Certified trainer of incoming employees on aseptic activities in biosafety cabinets, as well as the use of bench top equipment, small scale bioreactors, LIMS, DeltaV, and SAP Performed role of acting Team Lead during Team Lead’s absence. Duties included schedule… Show more Experienced aseptic operator, familiar with aseptic technique, and clean room behavior. Utilized aseptic and cell culture techniques to maintain an animal cell line and virus seed stock for the development of the influenza vaccine Certified trainer of incoming employees on aseptic activities in biosafety cabinets, as well as the use of bench top equipment, small scale bioreactors, LIMS, DeltaV, and SAP Performed role of acting Team Lead during Team Lead’s absence. Duties included schedule creation using Orchestrate, coordinating equipment and room PM’s, troubleshooting processing issues, authoring shift reports, and helping lead shift change Responsible for daily use, maintenance, and troubleshooting of biosafety hoods, and bench top equipment such as Vi-Cell Cell Analyzer, Glucose Lactate Analyzers, Blood Gas Analyzers, Tube Welders, Tube Sealers, Peristaltic Pumps, and Dosing Pumps Familiar with the setup and operation of wave, single use, and stainless steel bioreactors. With supervisor assistance, authored a new batch production record and edited associated SOP’s which helped streamline documentation and implementation of cell culture activities Assisted with daily logbook and BPR page reviews, as well as final reviews for batch production records Experienced with Clean in Place, Steam in Place, pressure tests, and filter integrity tests Show less



Biomanufacturing Training and Education Center

• Operations Intern

  • May 2016 - Dec 2016

  NC State Duties included sterilizing equipment/materials/biohazard trash; disassembling, cleaning, and reassembling 2L bioreactors; cleaning lab rooms and equipment; monitoring and recording batch cell growth; and preparing solutions and other materials: all while following SOP’s and recording results in log books.



BTEC

• Student

  • 2012 - 2015