Regulatory Affairs Specialist II

• Jan 2021 - Present

Quality Technician

• Mar 2020 - Jan 2021

Performs isolator cabinet sterility and purity analysis for animal vaccine per 9 CFR regulation. Investigates out-of-specification and out-of-trend events. Utilizes aseptic technique for gowning in to mode field sterile environment. Performs water quality analysis. Performs isolator cabinet sterility and purity analysis for animal vaccine per 9 CFR regulation. Investigates out-of-specification and out-of-trend events. Utilizes aseptic technique for gowning in to mode field sterile environment. Performs water quality analysis.

Quality Control Technician

• Apr 2018 - Mar 2020

ISO 13485:2016 Internal Auditor. Documents testing results and determines disposition of raw material and finished product. Reviews documentation for completeness, accuracy, and adherence to Good Documentation Practices. Reviews and maintains product compliance specifications and documentation control. Creates and edits Standard Operating Procedures, forms, and device master records. Uses microbiology skills and knowledge to troubleshoot potential issues. Participates in Quality and Management Review processes. Performs environmental and water system monitoring. Conducts facility-wide preventative maintenance and calibration audit each month. Conducts CAPA and complaint investigation and identifies root causes to support continuous improvement. Contributes to and embraces 5S Lean and PPI Culture. Familiar with SAP and MasterControl software.

Undergraduate Research Assistant

• May 2016 - Dec 2017

Operated autoclave, PCR thermocycler, spectrophotometer, nanodrop reader, microplate readers, and other lab equipment. Improved detail-oriented and aseptic techniques through increased application. Conducted PCR, transformations, gel electrophoresis, mutant screens, DNA extraction, etc. Prepared various selective, differential, and growth media for experimental use. Assisted in laboratory equipment maintenance and relocation. Operated autoclave, PCR thermocycler, spectrophotometer, nanodrop reader, microplate readers, and other lab equipment. Improved detail-oriented and aseptic techniques through increased application. Conducted PCR, transformations, gel electrophoresis, mutant screens, DNA extraction, etc. Prepared various selective, differential, and growth media for experimental use. Assisted in laboratory equipment maintenance and relocation.

Supervisor- James E Foy Information Desk

• Jan 2016 - Dec 2017

Required professional decorum and patron interactions from 30 overseen employees.Coordinated scheduling of employees in accordance with University standards.Participated in interviewing and hiring of new employees.Directed facility and patrons in the event of severe weather or emergency situations.Provided customer service and problem solving in the event of issues and grievances.Locked and closed the building down at the end of the business day.

Desk Assistant- James E. Foy Information Desk

• Sep 2014 - Dec 2015

Answering phones, providing information, regulating room reservations, communication, and customer service.

Camp Commissioner

• May 2013 - Jul 2014

Quality control, campsite inspection, direction of daily Scoutmaster meeting, communication, and program oversight. *This job was held in the summers of 2013 and 2014. Quality control, campsite inspection, direction of daily Scoutmaster meeting, communication, and program oversight. *This job was held in the summers of 2013 and 2014.