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Mariana O. is a seasoned quality control professional with experience in pharmaceuticals, healthcare, and manufacturing. She holds a Bachelor of Biology degree and has certifications in Project Management, Six Sigma, and Phlebotomy. Mariana is proficient in Portuguese and English and has worked in various roles, including Quality Assurance, Donor Center Specialist, and Verifier.

Credentials

  • Project Management: Healthcare Projects
    LinkedIn
    Mar, 2023
    - Apr, 2026
  • Six Sigma Principles
    University System of Georgia
    Apr, 2022
    - Apr, 2026
  • Six Sigma Tools for Analyze
    University System of Georgia
    Apr, 2022
    - Apr, 2026
  • Six Sigma Tools for define and Measure
    University System of Georgia
    Apr, 2022
    - Apr, 2026
  • Six Sigma Tools for Improve and Control
    University System of Georgia
    Apr, 2022
    - Apr, 2026
  • Patient Safety and Quality Improvement
    The Johns Hopkins University
    Nov, 2020
    - Apr, 2026
  • National Certified Phlebotomy Technician
    National Healthcare Certification Organization
    Nov, 2021
    - Apr, 2026
  • HIV/AIDS - 9th edition - Implications for Nurses and Other healthcare professionals
    University of Washington
    Sep, 2020
    - Apr, 2026
  • Certified Medical Assistant (CMA)
    Grifols
    Apr, 2020
    - Apr, 2026
  • NHA-Certified Phlebotomy Technician (NHA-CPT)
    Grifols
    May, 2019
    - Apr, 2026
  • Basic Life Support (BLS)
    American Heart Association
    Aug, 2020
    - Apr, 2026
  • First Aid/CPR/AED for Schools and the Community
    American Red Cross
    Jun, 2020
    - Apr, 2026
  • Basic Patient Blood Management
    AABB
    Nov, 2020
    - Apr, 2026

Experience

    • Quality Control Inspector
      • Aug 2023 - Present

    • Quality Assurance
      • Apr 2023 - Aug 2023

      •Understand and execute procedural requirements for the QA verification of processes.•Performs quality review of manufacturing documentation for Compounding, Cleaning and Packaging verification processes•Release and determine the need to place production equipment and or utensils on QA hold as directed by procedure.•Issue and monitor the Clean and Use Logbooks for Manufacturing across all facilities.•Responsible for notifying QA Supervisor/Manager of any documentation discrepancies and or requirements for QA Holds.•Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state, and local regulations.

    • Spain
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Quality Assurance Specialist
      • May 2022 - Mar 2023

      Responsible for daily donor record file review.Perform equipment quality control review - daily, weekly, monthly, semi-annual and annual.Perform a review of donor center records.Perform weekly review of equipment incident logs.Verification and release of sample shipment.Perform Staging of plasma for shipment.Inspection and release of incoming supplies.Perform Weekly employee observations.Participate in the Quality Assurance meetings and be part of the Quality Assurance team.Assist the Center Quality Manager to ensure that cGMP regulations are followed.Assist the Center Quality Manager to ensure that SOPs are followed and regulatory requirements are met.Performs a review of the documentation of unsuitable test results and the disposition of the associated units.On an occasional basis, when the Center Quality Manager is absent, the Quality Associate may be required to perform the following duties:Performs all product release activities.Documents, investigates, and performs root cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.Review of equipment records and DMS information if applicable to approve out of service machines for use.Review and approval of deferred donor reinstatement activities.Perform a review of lookback informationWaste shipment reviewInitiates investigations and reports any supplies that have not met quality specifications and requirements prior to use.Perform a review of medical incident reports and the applicable related documentation.

    • Donor Center Specialist
      • Mar 2022 - May 2022

      Responsible for maintaining active communication with other service areas to ensure accurate documentation and quality.Build reports with donors to ensure overall customer satisfaction with the center to support long-term donations.Learn and maintains thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.Report all unsafe situations or conditions to the area lead, supervisor, or manager.Initiates investigations and reports any supplies that have not met quality specifications and requirements prior to use

    • Plasma Processor
      • Jan 2021 - Mar 2022

      Responsible for donor samples collection for processing and testing. Recorded weight of product and samples. Labeled samples and froze units for final packing within the required timeframe.Participated in unit management according to SOP.Packed units for final shipment. Packed samples and prepares shipping boxes to send samples to the testing lab.Monitored stored products to ensure time requirements are met Monitored and reported working conditions of equipment.Communicated with other areas to ensure accurate documentation and quality.Completed all necessary documentation.

    • Donor Center Technician
      • Jul 2019 - Mar 2022

      Conducted pre-donation medical screening in accordance with established guidelines. Determined Hematocrit (HCT) and Protein via finger stick and use of the hemostat and refractometer. Promoted customer satisfaction through appropriate interaction and responsiveness to customer needs.

    • Phlebotomist
      • Jan 2019 - Mar 2022

      Responsible for assisting in determining the suitability of donors to undergo plasmapheresis prior to venipuncture. Monitors donors and equipment to ensure the health of donors and the quality of the product. Sets up, disconnects, and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc. Ensure the proper calibration and maintenance of autopheresis machines and associated equipment. Follow and keep up to date with all state and federal regulations, FDA-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal company procedures.

    • Verifier
      • Aug 2018 - Dec 2018
      • Washington

      Responsible for shipments and detecting missing products;Detecting missing products e unloading and stocking materials;Checking invoice accuracy.

  • Insight Global
    • Bellevue Washington
    • Microsoft Research
      • Mar 2018 - Aug 2018
      • Bellevue Washington

      Research for the project Captions in Brazilian Portuguese;Research for the Microsoft face recognition project. Features include face detection that perceives facial features and attributes — such as a face mask, glasses, or face location — in an image, and identification of a person by a match to your private repository or via photo ID.

    • Assistant Teacher
      • Aug 2017 - May 2018

      Responsible in assisting the principal teacher in providing the kids with a cultural immersion by letting them learn Brazilian Portuguese from a native speaker.

    • Inter Exchange Student
      • Feb 2015 - Feb 2017
      • United States

      Cultural Inter Exchange program, language development and studying abroad.

  • Cdb - Centro De Diagnosticos Brasil
    • São Paulo e Região, Brasil
    • Client Service Assistant
      • Dec 2014 - Jan 2015
      • São Paulo e Região, Brasil

      Responsible for scheduling exams / appointments with customers by phone.

  • Fidelity Processadora - FIS
    • São Paulo e Região, Brasil
    • Billing representative
      • Feb 2013 - Dec 2014
      • São Paulo e Região, Brasil

      Responsible for answering calls and performing a friendly collection. I would locate and notify clients of outstanding invoices by telephone.

    • Recepcionist
      • Feb 2012 - Nov 2012
      • São Paulo e Região, Brasil

      Responsible for scheduling appointments with customers and the pest control technicians; Provided the customers with information about the pest control procedure

  • Pernambucanas
    • São Paulo e Região, Brasil
    • Billing Representative
      • Jun 2009 - Feb 2012
      • São Paulo e Região, Brasil

      Responsible for making friendly collection calls, locate and notify clients of outstanding invoices by telephone.

Education

  • 2011 - 2014
    FACIS - Faculdade de Ciências da Saúde de São Paulo
    Bachelor of Biology, Biology/Biological Sciences, General
  • 2015 - 2015
    University of Washington
    Advanced Conversation Course, English

Suggested Services

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Industry Focus. “Health, Wellness and Fitness”

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