Aisling Whiddon Email & Phone Number

Herndon, Va, Us

Manassas, Virginia, United States

Chantilly, Virginia, United States

Responsible for routine monitoring of quality control data for abnormal shifts and trends. Create and maintain records of ongoing instrument maintenance, temperature and humidity monitoring, continuing education, training and competency, nonconformances or process deviations and the corresponding corrective actions and patient impact. Establish and monitor quality control acceptance ranges, adjusting and tightening them as more data is available. Review SOPs and provide recommendations to document owners for quality improvements. Develop and lead in continuous process improvement activities. Perform ongoing compliance audits, generate reports of findings with corrective recommendations, and conduct follow-up audits to assure completion and effectiveness of corrective actions. Provide support and respond during regulatory audits. Coordinate survey sample testing and reporting, alternative performance assessments, and instrument/method comparison studies to comply with regulatory compliance.Accomplishments:o Project managed procurement, implementation, and training of AdobeSign software for quality records increasing overall productivity as well as responsiveness of remote employees.o Developed excel macros to automate multiple critical processes reducing time spent from days to hourso Completed Bronze certification in the Quest Management System used for continuous improvement.o Participated in preparation and completion of ISO 15189 certification for a 120,000+ sq. ft. laboratory that processes 50,000+ samples a day.o Served as Community Outreach and Education Co-Chair for the company’s national Pride resource group, establishing relationships and partnerships with nationally recognized advocacy groups including HRC, GLAAD, and The Trevor Project.

Chantilly, Virginia, United States

Responsible for routine testing of incoming patient samples. Analyze Lead, Magnesium, Selenium, Lithium, Chromium, Iron, and Iodine via ICP-MS. Work with a variety of sample types including Whole Blood, Packed Red Blood Cells, Plasma, Serum, and Urine. Maintain working knowledge of testing procedures, methodology, and clinical significance. Perform and maintain records of instrument performance maintenance according to established internal and vendor recommended schedule. Prepare and validate assay calibration materials. Perform instrument validation testing to add new assays and bring instruments up after major repairs. Complete ongoing continuing education. Maintain competency on all trained tests.Accomplishments:o Completed new technologist training program for those with a science background, but no clinical experience.o Successfully trained and signed off on twice as many assays as assigned during initial training to be more versatile to the department.

Middletown, Va

Responsible for establishing and maintaining schedule on a project to reformat product master record documentation in order to reach compliance with regulatory requirements. Perform as a member of the team as technical lead for the project and as a technical writer. Provide regular status updates to the senior project manager and maintain constant communication regarding problems and proposed solutions. Coordinate with leadership and personnel across planning, production, quality assurance, product support, and research and development to assure accuracy, completeness, and functionality of reformatted documents. Shadow production employees from beginning to end of the process to capture tribal knowledge and improve documentation and training for future employees. Maintain working knowledge of Abbott Laboratories clinical chemistry and immunoassay assays and instrumentation. Assure compliance of produced documents with ISO 13485, FDA regulations, international regulations, customer requirements, and the Medical Device Single Audit Program. Assure strict adherence to document control policies. Accomplishments:o Reformatted 1500+ documents and completing and delivering the project 4 months ahead of the established schedule.o Expanded documents from an average of 4-6 pages to an average of 20-25 pages due to the volume of tribal knowledge discovered missing and the amount of required documentation that was not present in the original documents.o Participated in GEMBA walks of the factory and completed training and certification in the company’s Practical Process Improvement program including root cause analysis and kaizen facilitation.

Middletown, Va

▪Responsible for directing day-to-day responsibilities of in-process and finished product testing for a team of 6-8 employees. Lead test failure investigations, perform root cause analysis, and report findings and corrective actions. Provide status updates during customer calls on laboratory projects. Perform laboratory data review and release of product from the laboratory for filling or shipment to customers. Participate as the laboratory representative in product failure investigations and respond during customer audits. Develop validation protocols and addendums and perform equipment validations on new or repaired laboratory instruments. Take ownership of laboratory Standard Operating Procedures and Test Methods and perform regular review and updates as needed. Perform laboratory testing of Abbott Laboratories Clinical Chemistry and Immunoassay in-process, finished product, and on-market stability samples. Act as a subject matter expert for the laboratory during customer and regulatory audits. Conduct initial training for new employees on laboratory processes and procedures.Accomplishments:o Acted as the interim team-lead for six months and maintained production and shipping timelines with no delays due to laboratory testing.o Lead the laboratory investigation of a major customer complaint against an ammonia reagent for the Beckman Coulter AU Series instruments.o Completed training as subject matter expert on Abbott Laboratories Alinity c series instruments and reagents.

Middletown, Va

Responsible for leading laboratory operations of a large product transfer project for a new customer. Travel between Virginia and New York for process mapping, instrument training, and production shadowing. Arrange delivery and installation of new laboratory instruments and facility modifications necessary to support them. Write and perform validation of new laboratory instruments. Write standard operating procedures and test methods to support new instrument and product testing. Participate as a team member in the correction action process. Develop and implement process improvement solutions according to the company’s practical process improvement model for continuous improvement. Perform laboratory data review and release of in-process and finished products from the laboratory.Accomplishments:o Integrated six new chemistry analyzers into the laboratory and performed all validation activities.o Completed training as a super user and subject matter expert on Ortho Clinical Diagnostics VITROS® family of chemistry analyzers.o Completed training as a laboratory data reviewer a year earlier than usual and became one of the primary reviewers with a spotless release record.

Middletown, Virginia

Responsible for testing of incoming raw materials, in-process and finished product samples, and on-market stability samples in the analytical chemistry laboratory. Conduct basic laboratory training for new technicians on pipettes, analytical balances, pH meters, and auto-titrators. Participate in root cause investigations and corrective action implementation. Perform air, surface, and water environmental monitoring activities and maintain database of results. Maintain the instrument performance maintenance schedule and assure completion by vendors within required time frames.Accomplishments:o Completed initial technician training in 50% less time than planned taking over full testing responsibilities for assigned products six weeks ahead of schedule.o Collaborated with QC Scientist to determine root cause of pH testing failures, standardized the meters and probes used throughout the factory, updated required maintenance and test procedures, and performed retraining of all laboratory and formulation personnel.o Served as subject matter expert for raw material testing and environmental monitoring for ISO 13485, FDA, and customer audits.o Completed document change control training, updated 50+ analytical test methods to be more dynamic, and provided reasoning and justification for the changes.

Winchester, Va

- Manage 3-8 employees within 6 departments while on duty 3 days per week- Coordinate day-to-day activities of a fitness center with 5000+ members- Communicate with senior management on events and incidents within the facility and assist in developing and implementing new policies and procedures as necessary- Cooperated with a team of managers to develop a new mission statement and core values specific to the center

Martinsburg, Wv

- Acted as part of the states quick response team- Trained for basic law enforcement duties, combat support, riot control, and disaster relief- Achieved rank of E-4 (Specialist)- Honorable Discharge for Medical Reasons

Bachelor’S Degree, Biology, 3.44 / 4.00

Dean's List - Fall 2013, Fall 2014 Concentration: Microbiology

Biology

Dean's List: Fall 2011 Completed 54 Credits toward B.S. completed at George Mason University

Bachelor’S Degree, Political Science, 2.93 / 4.0

Activities and Societies: Young Democrats at Virginia Tech – Spring 2008 – Spring 2009 - Outreach Chair, Fall 2008 Virginia Tech Union.