Heidi Schroeder

Quality and Regulatory Affairs Specialist at Memorial Blood Centers
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Contact Information
us****@****om
(386) 825-5501
Location
St Paul, Minnesota, United States, US

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Credentials

  • Information Mapping Associate
    Information Mapping
    Feb, 2023
    - Oct, 2024
  • Certified Quality Auditor (CQA)
    ASQ - World Headquarters
    Dec, 2017
    - Oct, 2024
  • CPR Instructor
    American Heart Association
    Nov, 2015
    - Oct, 2024
  • Yellow Belt Certification
    -

Experience

  • Memorial Blood Centers
    • United States
    • Hospitals and Health Care
    • 100 - 200 Employee
    • Quality and Regulatory Affairs Specialist
      • Mar 2016 - Present

      Perform QA review of all applicable systems including error management, auditing, variances, PDI's and Lookbacks. Submit BPDR's to the FDA. Perform internal audits and host external auditors. Participate in Change Management. Available as resource for all departments with questions or concerns regarding regulations and/or standards. Read and understand the CFR, FDA guidances, AABB Standards and other applicable rules and regulations to ensure compliance.

    • Donor Suitability Specialist
      • Mar 2014 - Mar 2016

      Review, monitor and trend daily errors. Determine if a unit or donor's safety/acceptability was compromised. Complete PDI investigations. Field phone calls daily regarding donor suitability. Participate in company wide projects.

    • Operational Supervisor
      • Apr 2012 - Mar 2014

      Oversee collection staff in daily operations of blood collection across multiple donation sites. Monitor staff performance, draw goals and daily operation. Assist in organizational projects. Provide staff feedback. Coordinate cell therapy collections for apheresis nurses.

  • BIOLIFE PLASMA SERVICES
    • United States
    • Pharmaceutical Manufacturing
    • 400 - 500 Employee
    • Assistant Manager
      • Sep 2005 - Apr 2012

      Started as entry level in Mounds View, MN. Left when an Assistant Manager in Hayden, ID. Roles included lead, supervisor, management, and quality tech. Performed daily operations in all areas. Completed management duties including staff performance feedback, donor counseling and inspection hosting. Completed quality duties related to internal auditing and served as Quality Managers in their absence. Started as entry level in Mounds View, MN. Left when an Assistant Manager in Hayden, ID. Roles included lead, supervisor, management, and quality tech. Performed daily operations in all areas. Completed management duties including staff performance feedback, donor counseling and inspection hosting. Completed quality duties related to internal auditing and served as Quality Managers in their absence.

Education

  • Ashford University
    Bachelor’s Degree, History
    2010 - 2012

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