Elbethel Hagos

QC Data Reviewer, Site Operation at Pharmaron
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Contact Information
us****@****om
(386) 825-5501
Location
College Park, Maryland, United States, US
Languages
  • Amharic Professional working proficiency
  • Tigrinya Professional working proficiency
  • English Full professional proficiency

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Bio

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Credentials

  • CITI Good Clinical Practice Course
    CITI Program
    Dec, 2022
    - Nov, 2024
  • Good Laboratory Practice (GLP)
    CITI Program
    Nov, 2022
    - Nov, 2024

Experience

    • China
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • QC Data Reviewer, Site Operation
      • Nov 2022 - Present

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Documentation Specialist, Analytical Development
      • Aug 2020 - Jun 2022

      • Drafted and revised client specific standard test methods, development studies, bridging studies, qualification protocol, and method qualification reports for the following analytical methods: titer ddPCR, residual ddPCR, infectivity by TCID50, ELISA, CE-SDS, SEC, U/HPLC, and cell culturing/seeding and maintenance • Shepherd document packages through the internal and client review process while liaising with clients, quality control, quality assurance, project management, and document control departments • Resolved internal and client comments on standard test methods, qualification reports and data package in a timely manner • Managed and ensured timely closure of all TrackWise records, deviations, change controls, CAPAs, laboratory investigations and events, within the Analytical Development Department • Served as compliance specialist for Analytical Development. Identify gaps in compliance (at a Tactical level) and develop solutions (at a Tactical and Strategic level) to resolve them. • Identified documentation and workflow gaps and setup single point training to close the gap • Leads and participates in continuous improvement initiatives to improve test method documentation, SOPs, employee training, and document and data review processes and procedures • Created new chemical inventory tracking system for QC and AD department • Served as SharePoint, Teams, and SmartSheet expert for AD department in the absence of IT support Show less

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Manufacturing Documentation Specialist
      • Mar 2020 - Aug 2020

      • Assisted in document storage, organizing, and archiving of unexecuted and completed batch records and protocols • Utilized tracking systems to distribute document correction notifications and monitor statuses • Prepared routine metrics on manufacturing documentations • Worked alongside chemists to ensure all necessary corrections are made in accordance with Good Manufacturing Practice Standards • Performed review of manufacturing records and logbooks • Created MBRs, SOPs, batch records and various documentations as needed • Issued work orders Show less

    • United States
    • Higher Education
    • 700 & Above Employee
    • Chemistry Lab Instructor
      • Aug 2019 - Mar 2020

      Evaluate and grade students' class work, laboratory performance, assignments, and papers.Prepare and deliver lectures to undergraduate students on topics such as inorganic chemistry, analytical chemistry, and chemical separation.Prepare course materials such as syllabi, homework assignments, and handouts.Monitor students' compliance with safety rules for handling chemicals, equipment, and other hazardous materials.Supervise undergraduate research work.Maintain regularly scheduled office hours to advise and assist students.Write grant proposals to procure external research funding. Show less

    • Lab Technician supervisor
      • Feb 2016 - Aug 2019

      Compile and interpret results of tests and analyses.Set up and conduct chemical experiments, tests, and analyses, using techniques such as chromatography and spectroscopy.Provide and maintain a safe work environment by participating in safety programs.Prepare chemical solutions for class and research use.Order and inventory materials to maintain supplies.Oversee staff of 5 lab technicians, training them in sample preparation and lab techniques.Identified, troubleshoots, and resolves complex issues associated with lab equipment’s and experiments.Maintain and calibrate lab equipment such as balances, pH probes, GC and etc. Show less

    • United States
    • Higher Education
    • 700 & Above Employee
    • Instrument Method Lab Project Leader
      • Feb 2018 - May 2018

      Conduct quality control tests. Prepare test solutions, compounds, or reagents for laboratory personnel to conduct tests. Study effects of various methods of processing, preserving, or packaging on composition or properties of foods. Used GCMS to analyze semi-volatile organic compounds in fuels and to quantify Limonene and α-Terpineol in Orange and Lemon oils. Gathering and integrating data from disparate sources. Using different software’s to analyze big data. Worked with Atomic Absorption spectroscopy to determine calcium and magnesium in milk. Show less

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Pharmacy Technician and customer service
      • Jul 2017 - Feb 2018

      Receive written prescription or refill requests and verify that information is complete and accurate. Establish or maintain patient profiles, including lists of medications taken by individual patients. Maintain proper storage and security conditions for drugs. Prepack bulk medicines, fill bottles with prescribed medications, and type and affix labels. Clean and help maintain equipment or work areas and sterilize glassware, according to prescribed methods. Receive written prescription or refill requests and verify that information is complete and accurate. Establish or maintain patient profiles, including lists of medications taken by individual patients. Maintain proper storage and security conditions for drugs. Prepack bulk medicines, fill bottles with prescribed medications, and type and affix labels. Clean and help maintain equipment or work areas and sterilize glassware, according to prescribed methods.

Education

  • University of Maryland
    Bachelor's degree, Biochemistry
    2017 - 2019

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