Morgan Yorkell

QA Regulatory and Compliance at Precision Science, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Tempe, Arizona, United States, US
Languages
  • English -

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Experience

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA Regulatory and Compliance
      • Mar 2023 - Present

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Sterility Assurance Specialist
      • Jan 2022 - Mar 2023

    • Sterility Assurance
      • Sep 2020 - Mar 2023

      Environmental monitoring of ISO 5, 6, 7, 8 and U/C areas based off of FDA 21 CFR and AATB regulations for static and dynamic processes Passive/ active air settling monitoring Non-viable particle monitoring Surface monitoring Personnel Monitoring Isolator monitoring Data collection, organization, analysis, and pathogen classification of environmental monitoring and sample testing data Quality testing of reagents and incoming materials Generate monthly/quarterly… Show more Environmental monitoring of ISO 5, 6, 7, 8 and U/C areas based off of FDA 21 CFR and AATB regulations for static and dynamic processes Passive/ active air settling monitoring Non-viable particle monitoring Surface monitoring Personnel Monitoring Isolator monitoring Data collection, organization, analysis, and pathogen classification of environmental monitoring and sample testing data Quality testing of reagents and incoming materials Generate monthly/quarterly environmental monitoring reports Generate biologics reports for product release Generate environmental excursion reports, track and trend identified growth data Sample shipment of frozen, chilled, and ambient samples R & D research and quality tissue testing for SOP validation Compiling and reviewing of dose audit testing of samples Update/streamline environmental monitoring SOP’s and logbooks

    • United States
    • Software Development
    • 700 & Above Employee
    • Private Tutor
      • Sep 2018 - Sep 2020

      Tutor struggling, average, and advanced students in biology/microbiology/genetics and related fields both in person and online. Tutor struggling, average, and advanced students in biology/microbiology/genetics and related fields both in person and online.

    • United States
    • Wellness and Fitness Services
    • 1 - 100 Employee
    • Lead Microbiologist
      • May 2020 - Jul 2020

      Complete microbial quality testing on all materials for nutraceutical products Validation of in house methods by USP 2021/ 2022 Supervise lab technicians Assist with HPLC testing Create and update SOP’s Out of specification investigation reports Manage lab inventory, equipment calibration, cleanliness, quality Complete microbial quality testing on all materials for nutraceutical products Validation of in house methods by USP 2021/ 2022 Supervise lab technicians Assist with HPLC testing Create and update SOP’s Out of specification investigation reports Manage lab inventory, equipment calibration, cleanliness, quality

    • United States
    • Wellness and Fitness Services
    • 100 - 200 Employee
    • Microbiology Laboratory Technician
      • Mar 2019 - May 2020

      Daily duties include bacteria, pathogen, and probiotic testing utilizing Veriflow PCR and Biolumix machines well as AOAC methods. Additional lab duties include environmental and water testing, single colony streaking, and false positive verification. Responsible for obtaining and understanding results, drawing conclusions, and opening OOS reports. Experience evaluating and adjusting SOP’s and STMS. Personally responsible for ordering inventory, experience with business calls and… Show more Daily duties include bacteria, pathogen, and probiotic testing utilizing Veriflow PCR and Biolumix machines well as AOAC methods. Additional lab duties include environmental and water testing, single colony streaking, and false positive verification. Responsible for obtaining and understanding results, drawing conclusions, and opening OOS reports. Experience evaluating and adjusting SOP’s and STMS. Personally responsible for ordering inventory, experience with business calls and speaking to sales representatives. Proud member of the safety team, the 5S team, and the wellness committee. Cross trained in the chemistry lab on the MID/NIR/UV-Vis as well as TLC and ID confirmation microscopy. Show less Daily duties include bacteria, pathogen, and probiotic testing utilizing Veriflow PCR and Biolumix machines well as AOAC methods. Additional lab duties include environmental and water testing, single colony streaking, and false positive verification. Responsible for obtaining and understanding results, drawing conclusions, and opening OOS reports. Experience evaluating and adjusting SOP’s and STMS. Personally responsible for ordering inventory, experience with business calls and… Show more Daily duties include bacteria, pathogen, and probiotic testing utilizing Veriflow PCR and Biolumix machines well as AOAC methods. Additional lab duties include environmental and water testing, single colony streaking, and false positive verification. Responsible for obtaining and understanding results, drawing conclusions, and opening OOS reports. Experience evaluating and adjusting SOP’s and STMS. Personally responsible for ordering inventory, experience with business calls and speaking to sales representatives. Proud member of the safety team, the 5S team, and the wellness committee. Cross trained in the chemistry lab on the MID/NIR/UV-Vis as well as TLC and ID confirmation microscopy. Show less

    • United States
    • Higher Education
    • 700 & Above Employee
    • Biologist research assistant
      • Sep 2018 - Mar 2019

      Investigated the living and environmental conditions of peatlands utilizing chromatography with soil and gas samples. Observed, recorded, analyzed, and interpreted consumption and production data of samples Verified data integrity and accuracy Maintained lab cleanliness; cleaned, replenished, and organized supplies

    • Microbiology intern
      • Jan 2018 - Aug 2018

      Researched plasmid strain interaction with E. Coli and other bacteria strains to understand their effect on two-component regulatory systems Worked with enzyme, gene, and plasmid purification and extraction PCR, centrifuge, and chromatography proficient Kept a detailed notebook of all experimental steps and results Achieved an advanced bacteriology lab credit

Education

  • Arizona State University
    Bachelor of Science (B.S.), Biology/Biological Sciences, General
    2015 - 2018

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