Supported Manufacturing Downstream, Drug Product and Buffers as investigation lead and change record owner.

Consultant for Pfizer, INC. located in McPherson, KS.• Project lead to facilitate the addition of three (3) new autoclaves into the equipment preparatory areas of the Kansas facility.• Managed +15 people from different contract organizations to facilitate the addition of new autoclaves.• Maintained a project budget of +2.50MM throughout the duration of the project and coordinated changes requests as necessary.• Served as a technical expert on the sterilization of porous and non-porous commodities. • Performed cycle optimization of legacy systems to ensure that they consistently met the equilibration requirements for the load. • Executed the FAT, IOQ, and Performance Qualification on the new autoclaves including writing, reviewing and approving the documents prior to execution.• Supported the closure of multiple regulatory commitments from the remediation site of the project.

Consultant at United Therpeutics in RTP, NC• Performed cycle development for the autoclave installation at the site. • Wrote, Executed and pushed approval of the IOQ/PQ protocols for the autoclave, temperature control units (ie. refrigerators, freezers and incubators), and filter integrity testers for the site.

• Managed the supplier quality audit program, the supplier change notification program, the approved supplier list and special projects within supplier quality/incoming quality• Performed supplier quality audits, risk categorization assessments, risk mitigations, supplier quality audit report peer reviews, supplier change notifications, change requests, exception reports, SCARs, corrective and preventive actions, and effectiveness checks associated with supplier quality/incoming quality• Provided direct quality oversight to purchasing/procurement, receiving and manufacturing for new and existing supplier qualifications and defects• Maintained department SOPs, test masters, specifications and forms to ensure that they were compliant with regulatory guidance and updated applicable documents as necessary using the change control system• Supported site regulatory audits from a technical background for supplier quality/incoming quality

• Lead a cross-functional team that established a course of action for the remediation efforts associated with Vapor-Phase Hydrogen Peroxide (VHP) and Aseptic Process Simulation (APS) programs• Generated the site project validation plan for VHP which included a technical assessment of each system, a comprehensive summation of the validation history, and an overall assessment of the compliance of each system• Executed all stages of the validation life-cycle including installational qualification, operational qualification, performance qualification and requalification for various sterilization principles and equipment• Provided technical support and training opportunities while managing the use and maintenance of the Kaye validators in conjunction with commissioning and qualification validation activities• Maintained protocols, SOPs, specifications and validation plans to ensure that they were compliant with regulatory guidance• Updated applicable documents using the change control system, investigated validation deviations, and managed corrective actions• Managed multiple technicians and provided technical support for validation activities

• Supported the commissioning and qualification of the Bulk Processing Facility and Viral Pilot Plant addition• Startup protocol development for IQ/OQ/PQ as it applied to process equipment, TCUs and laboratory equipment• Generated summary reports and validation plan reports to summarize completed validation studies• Direct involvement with quality assurance to address protocol deviations and to determine a path forward for situations that would involve additional testing• Worked one-on-one with quality assurance to approve engineering protocols, deviations, and corrective actions• Coordinated vendor assisted installation and operational qualification of laboratory bench top equipment• Executed SIP commissioning and qualification using a kaye validator• Executed functional testing, spray coverage testing, data historian qualification and SOP qualification• Performed P&ID walk-downs, assessed for red-lines, and slope verification• Supported manufacturing with SOP development for Bulk Process Systems and the Viral Pilot Plant

• Supported Compliance Quality Assurance with the implementation of the Novartis Quality Systems• Organized the Novartis Quality Manual into sections based on need and prioritized their implementation across multiple departments in an organized and efficient manner• Monitored the implementation of the Quality Manual standards into local site SOPs and procedures.• Supported SMEs during implementation to drive GAPs and bring Quality Control systems into place for site readiness, inspection and production• Facilitated meetings with SMEs to determine potential GAPs between Global Quality Standards and SOPs• Created a process of identifying the GAPs for multiple departments and facilitated their efficient mitigation• Performed site quality risk assessments to determine site compliance with global standards

• Executed membrane filtration on samples from in-process, water and ancillary bioburden testing• Performed water endotoxin analytical testing (colorimetric determination)• Incubated, read and interpreted environmental monitoring plates using SDA, TSA, EMB and R2A selective media• Assisted chemistry department with the creation of mobile phases for analytical testing

• Performed good laboratory practices to promote safety and efficiency for the in vivo/in vitro biochemical research laboratories• Created general stock solutions and mobile phases for the analytical laboratories• Ordered supplies for the lab and kept inventory of the supplies