Experience

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  Texcell- North America

  • Frederick, Maryland, United States

  • Director of Quality Systems

    • Feb 2022 - Present
    • Frederick, Maryland, United States

    -Responsible for managing the Quality and IT divisions of the organization.-Provide strategic direction, planning, and execution to support the current systems with a focus on Growth & Innovation, Risk Management, and Systems Integration. -Development and execution of various initiatives to Quality and IT processes, structures, and systems to drive continuous improvement in support of regulatory compliance and achieving strategic and policy deployment objectives-Develops short- and long-term strategic plans for improvement and associated action plans and metrics.-Lead validation activities related to facility, equipment, processes and computerized systems. -Provide guidance for computer system validation plans and summaries in accordance with Part 11 and review/ approve all computer system validation deliverables.

• 

  ABL Inc.

  • Rockville, Maryland, United States

  • Quality System Specialist III

    • Oct 2020 - Feb 2022
    • Rockville, Maryland, United States

    -Review non-conformances for robust RCA, effective CAPAs, and corresponding effectiveness checks-Act as Compliance Project Manager for internal customers to ensure timely implementation and closure of Deviations, CAPAs, and other Quality records-Develop, trend, and present Quality metrics/KPIs to senior leadership team weekly, monthly, and quarterly-Manage and provide primary oversight of CAPAs, Deviations, and Metrics program-Act as Lead auditor for internal audits (Generating audit report, verifying resolution of findings)-Act as Co-host for client and regulatory inspections (Coordinating backroom, runners, and redactions)-Provide GMP, CAPA, Deviation, and GDP training to junior Quality associates and internal departments

• 

  MilliporeSigma

  • United States
  • Biotechnology Research
  • 700 & Above Employee

  • Quality Assurance Specialist III (Deviations)

    • Oct 2019 - Oct 2020

    -Critically review deviation reports, investigation memo, RCA analysis, and proposed CAPAs-Use complex RCA methods (FTA, 5Ys, etc) as part of deviation investigation and CAPA management -Lead process improvements projects to improve key Quality metrics and processes (RFT, OTD) -Mentor and train junior auditors in 1:1, small group, and classroom settings

  • Quality Assurance Specialist II

    • Oct 2018 - Oct 2019

    -Review batch and lab records from 6 departments for accuracy, completeness, and GLP/GMP compliance -Maintain lab inspection-readiness by conducting regular internal audits, writing concise audit reports, and recommending corrections to meet regulatory and internal needs -Represent QA in internal and client project meetings, providing feedback and exposing compliance risk-Regularly work on interdepartmental teams to coordinate project timelines for business and quality needs

  • Quality Assurance Specialist I

    • Sep 2016 - Oct 2018

• 

  University of Maryland School of Medicine

  • 655 W. Baltimore Street, Baltimore, Maryland

  • Neurology Research Assistant

    • May 2015 - Aug 2015
    • 655 W. Baltimore Street, Baltimore, Maryland

     Performed IHC on both animal tissue (100+ slides) and cells with fluorescent microscope analysis Perform small nerve tissue fixation, trimming, and staining on 80+ samples

• 

  University of Maryland School of Medicine

  • 655 W. Baltimore Street, Baltimore, Maryland

  • Neurology Research Assistant

    • May 2014 - Aug 2014
    • 655 W. Baltimore Street, Baltimore, Maryland

     Cultured neural crest stem cells and performed viability assays when engulfing nanoparticles Assisted in sterile surgical removal of rat brain, formaldehyde-based tissue fixation, and tissue embedding Perform IHC on rat brain cross-sections

• 

  University of West Florida

  • United States
  • Higher Education
  • 700 & Above Employee

  • Creation of Balb C’s cytotoxic T-Cell against B6’s major histocompatibility complex (MHC)

    • Jun 2013 - May 2014

    -Fed, cleaned, and husbanded 80+ B6 and Balb C mice in animal care room-Euthanized experiment mice, removed spleen using sterile surgery techniques, isolated lymphocyte via Ficoll/Percoll gradient-Cultured cytotoxic-T cell with diligent feeding and splitting

  • Phage Display for Tau Protein in Alzheimer's Patient

    • Apr 2013 - May 2014

     Developed 8 unique M13 phage displays for Tau and phospho-Tau protein in cerebral spinal fluids as an early indicator assay for diagnosis of Alzheimer’s  Trained lab technician on ELISA, Phage displays, Michaelis-Menten enzyme kinetics, dilutions, bacteria titering, and E. coli culturing techniques

  • Learning Center Tutor (Chemistry, Biology, Psychology, Math, and Physic)

    • Jan 2013 - May 2014

    Worked at UWF’s Learning Center, offering tutoring service for ~12,500 studentsLed small groups (4~8 students) and classroom review sessions (50+ students), explaining critical-to-learn concepts, generating a test bank, showcasing problem solving techniques, and coaching remedial students through courseworkExpanded service offered at the Learning Center by organizing and leading highly popular exam review sessions (300+ students) for Chemistry courses prior to exam

  • Immunology Teaching Assistant

    • Jan 2013 - May 2014

     Organized, inventoried, and prepared (aliquots, dilutions, sterilization) reagents for two immunology lab sections with weekly scheduled experiments for 60+ students Conducted weekly “dry-run” experiment to optimize weekly reagent use (15% reduction) Drastically lower immunology laboratory fee for mice stocks (~$60/mouse; 80+ mice in total) by personally feeding, cleaning, and husbanding mice in animal care room Assisted Instructor of Record in lecturing, troubleshooting, and managing 60+ students to ensure quality and time-efficient experiments including staining, IHC, PCR, ELISA, ELISPOT, SRID, Western blot, and other immunology-related assays

  • Synthesis, Purification, and Characterization of Novel Copper (I) Oxalate Complexes

    • Jan 2013 - May 2014

     Collaborated with peers to create copper (I) oxalate complexes with alkene ligands under air-free conditions (via glove box & nitrogen gas) in microscale experiments (milligram quantities)  Demonstrated novel synthesis pathway for Copper (I) oxalate complexes in cheap and available ethanol, drastically lowering cost and improving synthesis efficiency (95%+) Successfully crystallized and characterized synthesized copper (I) oxalate complexes by IR, NMR, Mass spec., and XRD analysis

  • Study of Histone Control over Tetrahymena vorax’s Macrostoma and Microstoma Differentiation

    • May 2013 - Aug 2013

    -Cultured Tetrahymena vorax axenically in sterile, enriched proteose peptone medium-Wrote and optimized SOP for nuclear isolation of T. vorax protocols for yield and purity

• 

  University of West Florida

  • United States
  • Higher Education
  • 700 & Above Employee

  • Creating cDNA of PR8 Influenza’s segmented genomes from infected MDCK cell

    • Mar 2011 - Jan 2012

    -Maintained and amplified T-cell and influenza-infected MDCK cultures-Synthesized and quantified 21 dsDNA influenza cDNA segments via RT-PCR and gel electrophoresis-Generated Plasmid-influenza construct using Gibson Assembly and nuclease/ligation rxn-Plasmid amplification and extraction in bacterial culture

  • Chemistry Teaching Assistant

    • Jan 2011 - Jun 2011

    -Graded 200+ exams for four General Chemistry II sections-Record information in excel and perform basic statistical analysis

• 

  Baptist Manor

  • 10095 Hillview Drive, Pensacola, FL

  • Nurse Assistant

    • Sep 2009 - May 2010
    • 10095 Hillview Drive, Pensacola, FL

    Helped nurses and other nurse assistants take care of patients. Duties involved ambulating, dressing, and feeding patients, maintaining a safe and clean patient room, assist with regular maintance of patient's medical conditions such as cleaning of colostomy pouch.