Marie Catherine Luna, MBA

Marie Catherine Luna, MBA

Pharmacy Technician II

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  • Timeline

  • About me

    GMP Documentation Specialist II

  • Education

    • Franklin University

      2020 - 2022
      Master of Business Administration 4.0

      Focus in Organizational Business

    • The Ohio State University

      -
      Bachelor of Science (BS) Biology, General

      Activities and Societies: Delta Omega Kappa

    • Walnut Hills High School

      -
  • Experience

    • Kroger

      Sept 2012 - Jul 2013
      Pharmacy Technician II

      •Worked as a pharmacy technician II, learned great customer service, received and delivered prescription orders, collected clinical information for pharmacists and addressed non-medical questions and concerns. •Filed records for the patient and pharmacy, including physician orders, inventory counting and other miscellaneous records. •Provided administrative support by answering phones, managing insurance billing and drafting pharmacy reports. •Assisted the pharmacists by preparing and packing prescription orders for dispensing. Duties include comprehending and interpreting orders, along measuring, labeling and packaging medications. Show less

    • L Brands

      Jul 2013 - Sept 2014
      Product Safety Coordinator

      •Prepared international safety assessments for all formulas in international global sale markets for Limited Brands Mast Global.•Supported to compile, write, edit, revise, audit and submit raw material assessments to a toxicologist. •Reviewed safety assessments to assure that the formulas and documents are in compliant with the European Union regulations.•Analyzed vendor specifications for each chemical composition present in the formulation.•Processed Optiva audits for Product Lifecycle Management. •Summarized Safety Harmonized Release templates Repeat Insult Patch Test, Preservative Efficacy, and various Safety in Use studies. Show less

    • Kdc/one, Columbus

      Sept 2014 - Sept 2016

      •Performed analytical chemistry procedures based on new and existing methodologies.•Operated analytical instrumentation such as GC, FTIR, Karl Fischer, TOC, UV-VIS and NMR.•Implemented color-matching procedures on various types of personal care products.•Validated analytical testing methodology used to control raw materials. •Provided quality control support reviewing and updating SOPs.•Executed numerous responsibilities in SAP. •Sampled and manually inspected all incoming raw materials associated with the production of personal care products.•Practiced all cGMP and other laboratory regulatory requirements. •Sampled raw materials with aseptic techniques.•Assisted Chemists in preparing reagents and equipment.

      • Quality Control Analytical Chemist

        Dec 2014 - Sept 2016
      • Raw Material Sampler

        Sept 2014 - Dec 2014
    • L Brands

      Oct 2016 - Oct 2019
      Global Product Safety Specialist II

      •Arrange International Safety Assessments according to the European Union Cosmetics Regulation•Approve compliant raw materials according to the Mast Global Ingredient Policy to be used in new personal care product development •Support internal and external toxicologists to prepare International Safety Assessments•Compile and review documentation to assure compliancy according to the European Union, United States and Canada regulations•Calculate formulations to assure the raw material activity is globally compliant•Analyze Material Safety Data Sheets, Certificate of Analyses, Specifications, Compositional Breakdowns and Impurity documentations to assure thresholds and limits are within the Mast Global Ingredient Policy Show less

    • Andelyn Biosciences

      Mar 2022 - now
      Quality Control Documentation Specialist II

      •Perform technical reviews on all Quality Control data in support of product release, stability, and client-specific projects•Audit laboratory processes to ensure test methods are compliant according to FDA Regulations and Good Manufacturing Practices•Establish a new technical review process to help streamline product release promptly whileperforming a thorough analysis of the data to ensure SISQP•Identify quality issues and provide suggestions for improvement according to Good Documentation Practices, Good Laboratory Practices, and Good Manufacturing Practices.•Provide continuous improvement processes to improve throughput time, mitigate risks, and increase productivity. •Trained individuals to improve efficiency and effectivity. Show less

  • Licenses & Certifications

  • Volunteer Experience

    • Tutor

      Issued by William H. Adams Youth Foundation
      William H. Adams Youth FoundationAssociated with Marie Catherine Luna, MBA
    • Mentor

      Issued by LifeTown Columbus on May 2015
      LifeTown ColumbusAssociated with Marie Catherine Luna, MBA
    • Rider

      Issued by Pelotonia on Aug 2017
      PelotoniaAssociated with Marie Catherine Luna, MBA
    • Walker

      Issued by American Heart Association on Aug 2022
      American Heart AssociationAssociated with Marie Catherine Luna, MBA