Anna Julia Adams

Experience

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  US Army

  Jul 2012 - May 2017

  Medical Laboratory Specialist

  Responsible for performing a variety of standardized routine and specialized tests, evaluating abnormal results, using and maintaining equipment, and setting up and monitoring elements of a quality control program. These tests and analyses on urine, blood, serum, plasma, other body fluids and tissue involve both manual and automated procedures.

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  Self Regional Healthcare

  May 2017 - Dec 2017

  Medical Laboratory Scientist

  • Operated different types of analyzers independently as well as performed manual testing procedures in Microbiology, Chemistry, Hematology and Immunohematology according to the laboratory’s standard operating procedures and to the College of American Pathologist’s (CAP) standards. • Performed moderate to high complexity testing in microbiology, immunohematology and chemistry as well as reporting found results accurately to physicians and other health care staff verbally and in writing.• Performed meticulous quality control procedures and calibrations on laboratory instrumentation as well as and maintained and troubleshooted analyzers and equipment in a clinical laboratory setting to ensure compliance with laboratory accreditation agencies such as College of American Pathologists (CAP). This includes the Stago Compact, Tango, Siemens Iris, Clinitek Advantus, Beckman Coulter Unicel DXH 800, Vista, Roche Electrolyte Analyzer, Centaur and Advanced instruments Osmometer Show less

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  Holy Cross Health

  Jan 2018 - Aug 2018

  Medical Technologist II

  Served as Medical Technologist II for the Microbiology section of the medical laboratory at Holy Cross Hospital. Apply federal and organizational regulations and procedures to administrative and scientific tasks. Receives, evaluates and processes routine and abnormal clinical specimens. Research federal and organization regulations to provide guidance on organizational process internal to the laboratory. Routinely performs technically demanding diagnostic procedures and high complexity manual and automated tests and reviews and correlates results upon test completion. Responsible for daily quality control and quality assurance protocols as well as reviewing and evaluating procedures. Proficient in microbiology stains, performing testing on cultures and interpreting antimicrobial sensitivity results while recognizing possible interfering substances. Tasked with reporting of critical results and assisting infectious disease physicians in the interpretation of microbiological test results. Routinely participates in laboratory proficiency testing by certifying agencies. Verifies correct instrument operation utilizing established procedures and quality control checks after adjustments and/or repairs were made. Routinely identifies the cause of common problems, made necessary repairs and documented corrective action taken. Handles unusual test requests to identify and resolve inconsistent test results, and the occurrence of unusual events, such as the possibility of the isolation of rare isolates and takes the appropriate action. Use automated systems to process data and administrative information. Show less

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  The National Institutes of Health

  Sept 2018 - Nov 2022

  ●Complies with accrediting and inspections agency requirements participating in activities associated with the laboratory accreditation process.●Plans, organizes, and executes validations for new instruments or testing techniques according to cGMP and FDA guidelines. ●Writes and reviews Standard Operating Procedures adhering to cGMP and FDA regulations. Also Maintains excellence in Good Documentation Practices.●Serves as the Molecular SME of the Sterility Testing Service. Responsible for training new employees on molecular technique, RT-PCR, and Sanger Sequencing.●Responsible for inventory and purchasing reagents for the Molecular Laboratory. ●Serves as technical expert on issues regarding evaluations, interpretations, and recommendations of data in final form for publications. Interfaces with senior scientific staff for final evaluation and reporting of results following analysis.●Receives, evaluates, and processes cell therapy products and environmental monitoring specimens from cGMP/aseptic processing facilities. ●Complies with cGMP requirements and demonstrated up-to-date knowledge of requirements while performing sterility testing activities in a cGMP/aseptic processing facility.●Performs method suitability and sterility testing on new cell therapy products and biopharmaceuticals manufactured at the NIH.●Experienced with handling and culturing Mycoplasma samples following USP<63>.●Extensive experience in molecular microbiology, Mycoplasma RT-qPCR testing and test troubleshooting and interpretation.●Provides expert scientific advice and consultation to senior staff in designing, coordinating, and maintaining scientific project goals.●Advises senior staff on purchasing new instrumentation, modifying specimen handling practices, adjusting primer and probe concentrations, and optimizing workflow and testing protocols.●Responsible for detailed record keeping of scientific projects, as well as budgeting for reagent and inventory purchases. Show less ●Applies federal and organizational (CAP and CLIA) regulations, policies, and procedures to all work●Recommends methods and, develops and modifies methods and procedures for conducting the project●Provides advice and consultation for Institute personnel regarding methods and techniques●Analyze and interpret data from automated systems. Keeps abreast of pertinent literature, extracts relevant details, and incorporates appropriate concepts and techniques into research activities and experiments●Determines deficiencies in methodology and takes appropriate corrective action, which may involve the evaluation of new or unfamiliar methods or protocols●Uses organizational automated systems to process and track project and scientific data●Receives, evaluates, and processes routine clinical specimens. Involved in quality control and analysis of specimen integrity prior to work-up for diagnostic procedures.●Routinely performs technically demanding diagnostic procedures and high complexity manual and automated tests, reviews and correlates results upon test completion●Performs rapid identification of microbiological agents causing disease in humans●Develops and modifies research methods and requirements when issues arise●Validates new test methodologies while maintaining complete and detailed records of experiments performedTowards projects and implementation of new procedures, I worked to compare the existing Onchocerca PCR using SYBR green based design to a newer TaqMan testing method. I modified the technique in order to improve the sensitivity and in alignment with phasing out of outdated equipment. Most recently, I was one of the main microbiologists who planned, conducted, and coordinated the validation of both the CDC based RT-PCR protocol and the WHO based RT-PCR protocol to detect COVID-19 in parallel for clinical samples. Throughout this process, we made adjustments in methods and procedures by means of validations to accommodate different specimen types. Show less

  • Clinical Laboratory Scientist - Sterility Testing Service

    Sept 2020 - Nov 2022

  • Clinical Laboratory Scientist - Microbiology

    Sept 2018 - Sept 2020
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  FDA

  Nov 2022 - now

  Regulatory Counsel

  Serve as subject matter expert responsible for reviewing and making recommendations on a large caseload of administrative enforcement actions involving the regulated industry.Develop policies and programs that affect tobacco product regulation.Draft and critically review policies and program proposals and decisions on tobacco product compliance and enforcement activities.Consult with staff at all levels of FDA to identify issues and areas of concern regarding compliance strategies.Communicate effectively across CTP, colleagues, and other stakeholders.Demonstrate knowledge of latest tobacco regulations and keeps abreast of changes in the external and internal environment.Apply knowledge of FDA and CTP laws, regulations, and policies by monitoring regulated industries to ensure these laws, regulation, and policies are equally enforced.Conduct sound investigations of suspected non-compliance of tobacco retailers.Extract information from a variety of databases, both within and outside the Agency, to determine compliance with applicable statutes or regulations.Collect, analyze, and interpret data and information, as well as drawing conclusions and making recommendations based on data.Provide guidance of regulatory requirements and compliance. Show less