Experience

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  Waltonwood senior living

  Nov 2009 - Apr 2013

  Medication technician/supervisor

  •Supervise medication technicians and caregivers to ensure the quality care of residents.•Manage last minute staffing issues and mediate issues•Obtain knowledge of and properly distribute medications prescribed by each resident's physician.•Provide basic first aid.

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  Pfizer

  Apr 2013 - Aug 2017

  •Abide by all rules and regulations set by the FDA and other regulatory agencies.•Perform environmental monitoring of the aseptic and other manufacturing and support areas including air, surface, water, and personnel monitoring.•Complete monthly reports on environmental monitoring data.•Update forms and standard operating procedures.•Participate in internal audits.•Approve various laboratory tests for the release of completed product batches.•Train personnel on sterile gowning.•Adhere to all SOPs and cGMPs.•Hazardous waste handler.•Site first aid team. Show less

  • Environmental Technician III, Quality Control

    Jan 2014 - Aug 2017

  • Wall Washer

    Apr 2013 - Jan 2014
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  Endo

  Aug 2017 - now

  •Perform review and approval of various documents including but not limited to specifications, method validations, test methods, and technical reports.•Provide final disposition of pre-commercial batches.•Compile product impact assessments prior to regulatory filings and prior to the release of new products at launch.•Review filing narratives prior to filing new products for approval with FDA.•Participate in internal and regulatory site audits.•Act as the quality assurance contact for all pre-commercial products.•Provide quality assurance review and approval of deviations, CAPA, and change controls within the Quality Management System (TrackWise).•Report weekly on site deviations and change controls. Report quarterly on site change controls. Show less •Perform environmental monitoring of the aseptic and other manufacturing and support areas including air, surface, water, and personnel monitoring.•Evaluate samples for microbial growth and colony morphology.•Complete monthly reporting on environmental, water, and personnel monitoring data.•Perform growth support testing for incoming media receivals.•Review and approve microbiological testing for product and material release.•Train personnel on sterile gowning and appropriate behavior within the sterile manufacturing areas.•Draft and execute protocols to support continuous improvement.•Investigate microbiological excursions. Show less

  • Regulatory Affairs Manager

    Jul 2022 - now

  • Senior Associate, Regulatory Affairs

    Jul 2020 - Jul 2022

  • Quality Specialist, Systems

    Jul 2018 - Jul 2020

  • Microbiologist II

    Aug 2017 - Jul 2018