Larissa K. Morales

Compliance Manager at Steri-Pharma LLC
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Contact Information
Location
Syracuse, New York, United States, US

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Experience

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Compliance Manager
      • Jul 2013 - Present

      Various roles to include: - Front room audit support for FDA, EMA, ANVISA, EAEU global regulatory inspections -Manage CAPA program - Manage Data Integrity program - Manage Annual Product Review - Manage a talented multi-disciplinary team to ensure training, document control, and EHS compliance - Provide Quality Assurance support as required Various roles to include: - Front room audit support for FDA, EMA, ANVISA, EAEU global regulatory inspections -Manage CAPA program - Manage Data Integrity program - Manage Annual Product Review - Manage a talented multi-disciplinary team to ensure training, document control, and EHS compliance - Provide Quality Assurance support as required

    • United States
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Embryologist
      • Jul 2012 - Jul 2013
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Various
      • Jul 2002 - Apr 2012

      Various roles to include: - Managing shelf-life stability program for commercially distributed sterile drug product - Managing laboratory of professional chemistry analysts - Chemistry raw material and finished drug product release testing - Led site Safety/EHS program - Department lead for Document Control Various roles to include: - Managing shelf-life stability program for commercially distributed sterile drug product - Managing laboratory of professional chemistry analysts - Chemistry raw material and finished drug product release testing - Led site Safety/EHS program - Department lead for Document Control

Education

  • SUNY Geneseo
    Bachelor of Arts - BA, Biology
    1998 - 2002
  • Syracuse University
    Master's degree, Nutrition Sciences

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