Experience

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  Tetracore Inc

  • United States
  • Biotechnology Research
  • 1 - 100 Employee

  • Quality Control Associate II

    • Oct 2023 - Present

    Performs, analyzes, and documents raw materials and final release testing as well as stability testing on commercial and government contract productsFollows SOPs including Quality Control (QC ) and non-QC documents in compliance with ISO 9001 and ISO 13485Follows all cGMPs outlined in SOPs and in compliance with ISO 9001 and ISO 13485 as well as FDA and USDA regulationsPerforms routine internal audits for compliance with ISO 9001 and ISO 13485Utilizes multiple instrumentation: ABI 7500/Fast, QuantStudio5, Bio-Rad, SmartCycler, TCOR-8Creates and validates DNA/RNA template stocks for materials testingTroubleshoots underperforming or failing singleplex and multiplex assaysTrains new team members on proper pipetting technique, serial dilutions, microscopy, PCR analysis, microbiological culture, gram staining, DNA extraction, and RT-PCR assaysParticipates in lab maintenance including instrument calibrations, general laboratory cleaning, purchasing supplies, and taking stock inventory

  • Quality Control Associate

    • May 2020 - Sep 2023

    Performed stability testing and recorded results on commercial and government contract productsDeveloped a new method of recording data for all products to include per lot comparison, data trending, and degradation of positive material templatesWorked independently on multiple stability studies to understand and determine storage conditions, product stability, and materials testing for assays including SARS and African Swine Fever and materials such as tube qualityQuantified templates of unknown concentration using ddPCR techniquesTrained new team members on how to test stability of productsFollowed SOPs including QC and non-QC documentsFollowed all cGMP outlined in SOPsReported all results and completions of tasks to QC managerParticipated in lab maintenance including general laboratory cleaning and sterilization

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  ATCC

  • Frederick, Maryland

  • Repository Technician

    • Feb 2019 - May 2020
    • Frederick, Maryland

    Followed all company policies governing operation of the Repository AreaPerformed all duties according to SOPs, Facility Safety Guidelines, and FDA requirements to include compliance of cGMP CFR 21 parts 210 and 211 where applicableOverhauled the repository freezer mapping system and implemented the new system to better organize study sample information and increase pull time efficiencyCreated a new system of organization for the freezer rack cage to sort racks by size and typePrepared samples for pickups, courier deliveries, and shipmentsAssisted in training of peers in the effective use of equipment, methods of storage and retrieval, and systematic data entryParticipated in temperature/liquid nitrogen (LN2) level monitoring, after-hours emergency response rotations, and documented alarms in response to the temperature monitoring systemWorked closely with supervisors in order to support customer inquiries, including discrepancies in shipments, inventory maintenance, and database updatesPerformed data entry of samples into a computerized database for sample tracking and managementVerified material prior to shipment and confirmed accuracy of data entry records for incoming materialsPerformed specimen consolidation and sterilization of freezers and tanks located in the repository

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  Biotest Pharmaceuticals Corporation

  • Orlando, Florida Area

  • Biomedical Technician

    • Aug 2018 - Nov 2018
    • Orlando, Florida Area

    ·At all times follow Standard Operating procedures, and responsible for remaining current regarding SOP changes.·Identify and screen donors by reviewing medical records and logs and evaluate the donor as to suitability. Screening includes asking health related questions and referring to medical staff when necessary; taking vital signs (blood pressure, pulse, and temperature), performing fingerstick (HCT & Total Protein), and reviewing results using the applicable donor management system to maintain donor confidentiality as all times.·Responsible for use of DMS, eQue, or NextGen·Responsible for preparing donors for plasmapheresis procedure. Collect plasma by setting up the autopheresis instrument, performing the venipuncture and utilizing an Automated Plasmapheresis machine.·Evaluate vein performance by checking data with known norms to identify possible problems; make corrections in order to expedite donation time and ensure quality. Conducts all phlebotomies in compliance with all federal, state, and Biotest regulations.·Draw samples utilizing a sterile technique with proper with proper use of PPE & equipment to assure the sterility and quality of units. Accurate data entry of product and donor information into the applicable donor management system. Responsible for sending sample shipments.·Record all pertinent information in donor record file or electronically and various logbooks, donor management systems, according to SOPs, maintaining 100% accuracy. Strong attention to detail.·Take plasma units to the freezer timely as determined per SOP to assure preservation of plasma proteins.·Maintain clean and efficient working environment including production areas, storage areas, Biohazard area & inactive record storage area. Maintain sufficient operating supplies & stocking supplies in production areas. Maintain proper storage, maintenance & cleaning of equipment and supplies used in production areas.

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  MedStar St. Mary's Hospital

  • Leonardtown, Maryland

  • Pharmacy Intern

    • Jun 2016 - Jul 2016
    • Leonardtown, Maryland

    Gained knowledge about the basic and most common medications and operations of an in-patient hospital pharmacy. Organized and designed new medicine management and pharmacy protocol binders for easier access and more efficient research. Entered reconciliation codes into controlled substances safe. Delivered medications to patients’ rooms. Performed inventory and restocked controlled and non-controlled substances. Attended safety and operational meetings for Joint Commission Protocols