Erica Pasch

 Erica Pasch

Erica L. Pasch

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Biography

Missouri Western State University - Biology


Resume

  • 2013

    Master of Applied Science

    Chemistry

    Missouri Western State University

  • 2006

    Bachelor's degree

    Biology

    Health Science

    Missouri Western State University

  • SOP development

    Chemistry

    Sop

    FTIR

    SAP

    Laboratory

    GMP

    Aseptic Technique

    Gas Chromatography

    GLP

    Validation

    Microbiology

    SOP

    USP

    Method Development

    SOP authoring

    Wet Chemistry

    Environmental Monitoring

    Pasch

    Pasch

    Heartland Hospital

    Missouri Western State University--St. Joseph

    MO

    Boehringer Ingelheim Animal Health - US

    Missouri Western State University--St. Joseph

    MO

    Hillyard

    Inc.

    Saint Joseph

    MO

    Support CMC Pharmaceutical Regulatory Affairs in pre-approval and post-approval compliance areas. Prepare and file FDA regulatory submissions. Review scientific/technical information related to regulatory submissions. Maintain advanced and current knowledge of relevant regulations

    policies

    and guidelines and act as CMC Regulatory Affairs SME. Provide guidance/direction within the regulatory department

    internal departments and CMOs relative to regulatory compliance of BI AH products and processes.

    Sr. Specialist

    Regulatory Affairs

    CMC Pharmaceutical Regulatory Affairs

    Boehringer Ingelheim Animal Health - US

    Laboratory instructor for the following courses: CHE104

    Fundamentals of Chemistry and CHE101

    Introduction to Chemistry.\n

    Missouri Western State University--St. Joseph

    MO

    Hillyard

    Inc.

    St. Joseph

    Missouri Area

    Developed SOP’s

    Methods

    and IQ

    OQ

    PQ for QC laboratory. SME for QC laboratory microbiological functions. Performed QC (chemistry/microbiological) testing on raw materials

    bulk

    and fill samples. Prepared and maintained records of testing as required under cGMP. Performed routine troubleshooting and repair on QC instruments. Performed routine environmental and USP purified water system monitoring. Created and lead microbiological contamination prevention and control training for Hillyard's production personnel. \n

    Microbiologist

    Saint Joseph

    MO

    Supported Antigen Production Unit with both aerobic and anaerobic seed work

    scale-up

    and fermentation. Preformed various laboratory tests

    such as gram stains

    streak plates

    cell counts

    environmental monitoring

    and inactivation testing. Acted as lead scientist for anaerobic bulk pilot batches and technical lead for process improvement change controls.

    Scientist II

    Boehringer Ingelheim

    Maintained and transferred stock cultures and fresh subcultures of bacteria for use in the laboratory. Prepared various nutrient media

    agar plates and broths

    for maintaining cultures and for laboratory exercises. Utilized the autoclave for sterilization of material used in laboratory and for elimination. \n

    Missouri Western State University--St. Joseph

    MO

    Chemistry Graduate Teaching Assistant

    Laboratory instructor for the following courses: CHE104

    Fundamentals of Chemistry and CHE101

    Introduction to Chemistry.\n

    Missouri Western State University--St. Joseph

    MO

    Histology Technician

    Processed tissue specimen for examination by the pathologists. Performed tissue stains. Maintained Entered specimens into the database. Maintained current policy and procedures for the department. Assisted with autopsies. \n

    Heartland Hospital