Maribel Santos

Microbiologist at Integer Holdings Corp. (formerly Greatbatch Medical)
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Contact Information
us****@****om
(386) 825-5501
Location
Tijuana, Baja California, Mexico, MX
Languages
  • English -
Skills

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Credentials

  • Kinetic LAL Testing
    Lonza

Experience

  • Greatbatch Medical
    • United States
    • Medical Equipment Manufacturing
    • 500 - 600 Employee
    • Microbiologist
      • Dec 2015 - Present

      • Bacterial Endotoxins test qualification and routine testing by kinetic-turbidimetric method (Lonza, Charles River) on finished good, subassemblies and raw material for medical devices per ANSI/AAMI ST72: 2012, USP <85> • Review compliance parameters, following and release of EO sterilization loads per ISO 11135:2014 • Creation and implementation of procedures for environmental (ISO 14644) and sterilization control • Environmental monitoring of certified controlled areas and equipment (viable and no viable particles and surfaces) • CEA certification per ISO 14644-1:2015 • Creation of engineering changes to update documents, formats and instructions by the document control electronic system • Validation and qualification of laboratory equipment and process (IQ, OQ, PQ) according to GLP • Preventive maintenance of laboratory equipment and creation of PM procedures • Software validation of laboratory equipment • Knowledge of Corrective and Preventive actions Show less

  • Harbor Compounding Pharmacy
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Control de Calidad
      • May 2013 - Nov 2015

      Farmacia de composicion hormonal. Tratamiento de reemplazo hormonal. Farmacia de composicion hormonal. Tratamiento de reemplazo hormonal.

  • SBL Pharmaceuticals
    • Químico Analista
      • Sep 2010 - Jun 2012

      Químico analista en el departamento de Control de Calidad, encargada del área de análisis microbiológicos. Responsable del muestreo y análisis del agua, ambiental, personal y productos fabricados en la empresa. Responsable del muestreo, análisis, aprobación y/o rechazo de toda materia prima y producto terminado en la empresa. Responsable del uso y mantenimiento del cepario bacteriano del laboratorio. Identificación de contaminación en productos y áreas.

    • Quimico Analista
      • Jun 2010 - Sep 2010

      Químico analista en el departamento de Control de Calidad para el análisis fisicoquímico. Responsable del muestreo, análisis, aprobación y/o rechazo de materia prima para la fabricación de medicamentos en la empresa.

    • Químico Analista
      • Oct 2009 - Jun 2010

      Químico de Desarrollo analítico, uso de equipo HPLC y equipo instrumental. Desarrollo de métodos de análisis y protocolos de validación para su aplicación en las nuevas formulaciones.

Education

  • Universidad Autonoma de Baja California
    Quimico Farmacobiologo, Química médica y farmacéutica
    2005 - 2010

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