Marianne Brown

Quality Risk Management Analyst at Cook MyoSite
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Contact Information
us****@****om
(386) 825-5501
Location
Pittsburgh, Pennsylvania, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 100 - 200 Employee
    • Quality Risk Management Analyst
      • Apr 2021 - Present

      Responsible for organizing and overseeing the quality risk management (QRM) program. This includes leading facilitation, communication, tracking, monitoring, and reporting of quality risk assessments and mitigation actions. Provide support to quality management system organization processes (investigations, CAPA, change control, etc.) as needed

    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Center Manager
      • Aug 2020 - Apr 2021

      Pittsburgh, Pennsylvania, United States Provided oversight of all center operations. This included creating a center roadmap to manage center finances, implementing local marketing plan, and managing center staff. Additionally, collaborating with all areas in the center, including the quality team to ensure that the center meets all regulatory requirements.

    • Assistant Manager of Quality
      • Jun 2019 - Jul 2020

      Greater Pittsburgh Area Core activities included providing quality oversight within the plasma collection center. This includes conducting regular self inspections, a daily review of documentation, and oversight of training within the center to ensure that Standard Operating Procedures (SOPs) are being followed. Investigations are performed for any deviations, along with developing Corrective and Preventive Actions (CAPAs). Additional tasks include the hosting of audits for FDA, PPTA, CLIA, etc.

    • General Supervisor of Quality
      • Sep 2018 - Jun 2019

      Cleveland/Akron, Ohio Area Day-to day duties in this role include supervising operations to ensure they are compliant with Standard Operating Procedures (SOPs) and applicable federal and local regulations as well as HR policies. This includes working to to identify problem areas and implementing corrective and preventative actions (CAPAs) based on the risk analysis. Duties as a supervisor include participating in a leadership development program, as well as leading projects to help develop staff. This includes aiding in… Show more Day-to day duties in this role include supervising operations to ensure they are compliant with Standard Operating Procedures (SOPs) and applicable federal and local regulations as well as HR policies. This includes working to to identify problem areas and implementing corrective and preventative actions (CAPAs) based on the risk analysis. Duties as a supervisor include participating in a leadership development program, as well as leading projects to help develop staff. This includes aiding in the recruitment, selection, and training of quality staff.

    • United States
    • Research Services
    • 1 - 100 Employee
    • Research Assistant
      • May 2018 - Jul 2018

      Canton, Ohio Area Duties included data management for clinical trials. This entailed the entry of medical records to an electronic database and ensuring that the databases are validated and ready for analysis, as per FDA standards. This was accomplished by working with the physician, monitors, sites, and the client to manage the data collection and resolve any queries.

    • United States
    • Software Development
    • 1 - 100 Employee
    • Quality Assurance Intern
      • May 2017 - May 2018

      Cleveland/Akron, Ohio Area Work with the development, marketing, and sales team to ensure customer satisfaction and resolve any problems. Specific duties include managing the software tracking board and HelpDesk, providing solutions for the sales team and customers, and collecting data on customer use of the product. The product is a movement tracking system that allows for at-home therapy for children with special needs.

    • Student Assistant
      • Jan 2017 - May 2018

      Cleveland/Akron, Ohio Area Duties include preparing and organizing the materials for the Chemistry Lab courses. This includes measuring chemicals, making sure the proper materials are gathered, and troubleshooting and repairing any broken equipment. Also, managing the student and chemical databases. This is all done in accordance to laboratory standards

Education

  • The University of Akron
    Bachelor's degree, Bioengineering and Biomedical Engineering
    2014 - 2018

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