Karin Shmaltz

Senior QA Associate at Ultraceuticals
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Sydney Area, AU
Skills

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Credentials

  • PIC/S GMP: PE 009-14 (SP6510)
    SeerPharma
    Jul, 2022
    - Nov, 2024
  • Introduction to Food Safety & HACCP Awareness (Food Safety Supervisor Training); FBPFSY1001 Follow work procedures to maintain food safety; FDFFS2001A Implement the food safety program and procedures; FDFPH1001A Follow work procedures to maintain GMP
    SAI Global Assurance
    Apr, 2019
    - Nov, 2024

Experience

  • Ultraceuticals
    • Personal Care Product Manufacturing
    • 1 - 100 Employee
    • Senior QA Associate
      • Sep 2022 - Present

    • QA Specialist
      • Nov 2019 - Aug 2022

  • Balfours Bakery
    • Australia
    • Food & Beverages
    • 1 - 100 Employee
    • QA Officer
      • Mar 2019 - Jul 2019

  • hylabs (Hy Laboratories Ltd)
    • Israel
    • Biotechnology Research
    • 1 - 100 Employee
    • Microbiology Quality Control (QC) Laboratory Manager
      • 2013 - 2018

      Position required responsibility for all the compliance activities within the QC laboratory: • Management of a staff of 8 laboratory technicians.• Approval / rejection of culture media product batches – final product disposition.• Professional customer support and technical assistance for all manufactured and imported culture media products (hundreds of products).• Conducted R&D evaluations of culture media for the microbiology market and managed laboratory experiments as well as stability studies for different products.• Represented the QC laboratory during audits of regulatory agencies and customers; performed internal professional quality audits and audits for company's suppliers.• Wrote, reviewed and approved protocols, reports and products’ Standard Operation Procedure (SOP) and Certificate of Analysis (CoA); handled of Change Requests (CRs), Deviations, Corrective and Preventing Actions (CAPAs) and Out of Specification (OOS) in collaboration with QA department.

    • Microbiology Quality Control (QC) Laboratory Technician
      • 2011 - 2013

      In this position I conducted QC tests for hundreds of culture media products according to products’ SOP and according to regulatory standards such as USP, ISO 11133, Standard Methods, CLSI and more. In addition, I conducted laboratory experiments and stability studies for different products and evaluated new raw materials.

    • Microbiology Service Laboratory Technician
      • 2009 - 2011

      Responsible for conducting microbiology tests for various cell therapy, medical device and pharmaceutical companies in a GMP environment and according to USP and ISO 17025 requirements:o Water testingo Bio-burdeno Microbial limit test (MLT)o Verification of spore populationo Environmental monitoring (Incubation and colony counting)o Bacterial identification (using different kits and instruments)o Mycoplasma culture

Education

  • Ben-Gurion University of the Negev
    Master of Science - M. Sc, Cum Laude, Desalination and Water Treatment Department
    -
  • Ben-Gurion University of the Negev
    Bachelor of Science - B. Sc, Chemistry
    -

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