Larissa K. Morales
Compliance Manager at Steri-Pharma LLC- Claim this Profile
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Bio
Experience
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Steri-Pharma LLC
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Compliance Manager
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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
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CNY Fertility
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United States
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Hospitals and Health Care
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1 - 100 Employee
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Embryologist
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Jul 2012 - Jul 2013
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Hanford Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Various
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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
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Education
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SUNY Geneseo
Bachelor of Arts - BA, Biology -
Syracuse University
Master's degree, Nutrition Sciences