Adelene Dunleavy, Cssyb (Asq) Email & Phone Number

Greater Phoenix Area

● Technical research to investigate the feasibility of new assays, instruments, and processes.● Work with IT&S and Marketing/Communication team for implementation of new or modifications to test offerings through database requests, client grams, and online marketing materials. ● Track and analyze current processes in molecular testing to identify trends that indicate the need for process improvements. ● Presented project plans and led the implementation of new assays and processes, ensuring alignment with organization goals and timelines. ● Conducted training sessions to educate staff on the use of new assays and processes, promoting adoption and adherence to established SOPs. ● Collaborated with cross-functional teams to ensure successful project implementation, fostering communication and coordination among stakeholders. ● 2023 Compliance Excellence and Ethics Award for continued efforts to bring in the full potential for EBV and BKV testing to maximize the savings for internalizing testing.

Phoenix, Arizona, United States

Phoenix, Arizona

• Supervise 12 employees in a high complexity testing CLIA certified laboratory, including preparing daily and weekly assignments for 7 laboratory technicians to prioritize and organize 12 assays with a 14 day turnaround time.• Quality Supervisor review for approximately 320 patient results per week for 448 different antigens using ELISA plate assays. Review of all failed runs to determine root cause and corrective action for repeat testing.• Troubleshooting all shifts and trends in calibrator values using Levey-Jennings charts for the positive and negative controls for each of the 448 antigens tested on ELISA plate assays.• Plate inventory for 448 different antigens. Supervisor review of all new plate lot QC, reference range comparisons, and plate lot changes.• Supervisor review on all reagent and control lot changes using %CV and L-J charts for comparison of data.• Client services communications including, preparing expected TAT release dates for all patient results nearing the 14th business day, response to rejected samples and stored sample volume, and reasons for delayed or longer than expected results. • Review of timecards, attendance records, and time off requests for 12 employees.• Attend and present at meetings for all staff, all supervisor staff, and client services and accessioning staff.

Tempe, Arizona

• Within this FDA licensed facility, performed confirmatory, supplemental and rWBC testing for 50-100 blood donors specimens on a daily basis. • Performed high complexity testing as regulated by CLIA regulations including ELISA, LIA, IFA, and Flow cytometry resulting in an average of 150 result reports weekly. • 2 years of testing NAT esas Procleix Ultrio assay testing that utilizes target capture and transcription meditated amplification for HIV-1 /HCV/HBV detection using illuminecences on small volume samples.• Responsible for following preventative maintenance sop's for testing equipment and Quality Control Assurance for instruments and micro-titer plates on a daily basis. • Supervision of test performance as describe in CLIA General Supervisor Role of the CFR's, including monitoring of data from daily Assay plate maps to ensure acceptable analytic performance, and ensuring review of all Preventative Maintenance records and Problem Isolation reports are completed. • Created 4 Training outlines, individual training checklists, and workbooks to help associates develop expertise associated with their assigned tasks.• Established rapport with blood donor centers via direct client phone calls concerning providing result reports on time, testing algorithms, and result interpretation. • Per facility sop's, performed an average of 3 equipment and 2 assay validations annually to validate installation, operation, and performance. • Contributing team member of an Operational Excellence 6S project to improve a small space into an efficient work area. • Responsible for following the DMAIC process by applying appropriate tools and input during meetings for corrective action and improvement efforts within the laboratory.

Madison, Wisconsin Area

• Within this FDA licensed facility, performed preparation of solutions that were used for detection of DNA on criminal cases.• Responsible for maintaining stock reagents and supplies as well as submitting purchase order requests as needed.• Performed calibration of PCR temperatures, and cleaned amplification rooms and DNA extraction hoods as required for weekly maintenance.• Executed quality control checks of all laboratory refrigerators and freezers as well as water bath and DNA extraction hood temperatures.• Performed a validation on Invitrogen's Charge Switch Technology extraction kit and used the information to compared to Progema's DNA IQ extraction kit as submitted this presentation to fulfill my internship for my senior project