Laboratory Operations Manager

SUMMARY OF QUALIFICATIONS

Accomplished and highly analytical professional, offering broad-based experience in directing all aspects of laboratory operations; backed by solid expertise in supporting clinical research and development tasks.

Hands-on supervisor, with proactive management approach in directing acquisition and maintenance of diverse laboratory equipment; while implementing critical initiatives and spearheading team efforts to optimize supplies and consumables storage for laboratories.

Systematic laboratory assistant and medical technician, with strong capability to conduct specimen collection and processing; apply standard protocols; and address challenges in fast-paced and demanding laboratory environments.

Effective leader, with proven skills in leading high-caliber teams and maintaining collaborative working relationships with laboratory personnel to ensure timely completion of assigned tasks and projects.

Former military enlisted; previously held a Secret Security Clearance.

AREAS OF EXPERTISE

Research Materials Inventory and Ordering

Bioanalytical Services Management

Equipment Usage and Troubleshooting

Data Research and Analysis

Proper Waste Disposal

Process Documentation and Reporting

Clinic Equipment and System Administration

Inventory Visibility Improvement

RELEVANT EXPERIENCE

Staff Supervisor ICON (now Laulima), Silver Spring, MD 2021–Present

Oversee and support laboratory, front desk, and recruitment staff at the Clinical Trial Center (CTC), while maintaining communication between the CTC manager and support staff.

Efficiently handle the onboarding of new personnel and execution of counseling activities, corrective action plan development, and performance assessment on annual basis.

Guarantee staff’s compliance with Good Clinical Practice (GCP) guidelines, Food and Drug Administration (FDA), and other military regulations.

Offer effectual assistance with the development of long-range plan and logistics for special projects; along with arrangement, procurement of clinic equipment, inventory, and purchasing system.

Perform all ad hoc duties in the recruitment, phlebotomy, laboratory processing, and front desk areas.

Support senior recruiter, clinical trials chief, public affairs office (PAO), and other CTC staff in the volunteer recruitment efforts which include production of recruitment materials, budgeting, and resource allocation.

Apply standard techniques and universal precautions for approved research protocols in conducting phlebotomy and specimen collections.

Implement necessary office space and staff cubicles adjustment in coordination with the clinical trials chief and CTC manager, while acquiring clinic, office, laboratory, and volunteer supplies, including laboratory equipment.

Maintain active participation in related safety training and communicate any infractions of safety procedures to the facility safety officer, while securing a safe workplace by observing appropriate safety and occupational health rules and regulations.

Medical Technician II Inotiv, Gaithersburg MD 2020–2021

Carried out and completed all laboratory testing on collected samples for clinical trials and toxicology studies using Provantis LIMS, the Dimension Xpand chemistry analyzer, and Advia 2120 hematology analyzer, as well as Clinitek Atlas for urinalysis and the ACL Elite Pro for coagulation testing.

Conducted operations and maintenance of laboratory’s analyzers and equipment, along with the management of required quality control records to guarantee accuracy and precision of analyzer.

Exemplified adeptness in facilitating manual testing of samples, including preparation and review of blood smears, reticulocyte smears, and urine microscopic examinations.

Performed clinical laboratory testing in adherence to Good Laboratory Practice (GLP) and internal standards.

Took charge of reviewing and interpreting data for acceptance and reporting purposes; gathering data and maintaining required documentation; and escalating sampling and testing problems to study directors and in-life technicians as needed.

Established, implemented, and assessed SOPs.

Strictly complied with universal safety precautions in handling blood samples and used required personal protective equipment (PPE) in dealing with potentially hazardous substances.

Data Management Specialist Smithers PDS LLC, Gaithersburg MD 2019–2020

Obtained pertinent data from primary and secondary data sources, while maintaining assigned database.

Collaborated with project managers, management, external sponsors, and central laboratory as needed.

Developed and managed project-specific contact lists.

Created discrepancy reports and advised project managers, sponsor, and relevant parties on discrepancies to determine and apply timely resolution.

Updated subject ID information and allocated custom IDs using Watson LIMS.

Evaluated and provided authorization for data transfer agreements with external sponsors and central laboratory.

Assisted in training newly hired employees as needed and responding to client, quality control (QC), and quality assurance (QA) audits and document deviations.

Medical Laboratory Technician Smithers Bioanalytical Services, LLC (via Aerotek), Gaithersburg, MD 2017–2019

Executed keen data review and laboratory quality control to determine potential problems on sampling and testing in partnership with study directors and in-life technicians.

Carried out general laboratory support functions, involving supply inventory, shipping procedures, computer systems administration, and data maintenance.

Ensured active involvement in multiple pre-clinical research studies simultaneously.

Laboratory Technician Center for Cancer and Blood Disorders, Silver Spring, MD 2016–2017

Utilized Medica EasyRA chemistry analyzer, Tosoh AIA-900 Automated Immunoassay Analyzer, and Beckman Gallios Flow Cytometer in performing daily laboratory testing for patients undergoing cancer treatment.

Observed strict compliance with the established protocols in conducting calibration and calibration verification as well as in executing all routine daily, weekly, monthly, and periodic maintenance and function checks.

Adhered to applicable procedures and protocol in repeating controls and troubleshooting problems on QC failure, including documentation of QC results in LIS and corrective actions on corrective action log.

Maintained adequate supply of all reagents and consumables for quality testing; logged purchased orders; labeled reagents and supplies with the date of receipt and opening.

Documented and verified patient test results through the LIS (LabDAQ) before releasing reports.

Handled the verification of any critical values by conducting repeat analysis as well as logging and reporting any critical values to physician or specified mid-level practitioner.

HIV Serology Medical Technologist Henry Jackson Foundation, North Bethesda, MD 2015–2016

Completed human immunodeficiency virus (HIV) serological and immunological assays based on laboratory SOPs, CAP, and FDA regulations.

Executed and documented all required weekly, monthly, semi-annual, and annual instrumentation maintenance.

Conducted western blot electrophoresis on Autoblot 3000 and Multispot HIV-1/HIV-2 rapid test for HIV differentiation; high-volume GS HIV Combo Ag/Ab EIA immunoassays using Bio-Rad EVOLIS and Elite Automated Microplate systems; and test results documentation through LIMS LabWare.

Properly aliquoted and stored high-volume numbers of specimens using four Beckman Coulter AutoMate 2550s.

Clinical Trials Laboratory Research Assistant/Coordinator ClinicalRM, Inc., Silver Spring, MD 2014–2015

Accomplished laboratory functions, including simple phlebotomy, unit collection, and specimen processing.

Assumed accountability for the procurement, maintenance, and transportation of blood specimens and samples for various tests and research projects in accordance with International Air Transport Association (IATA) guidelines, along with proper handling, collection, data entry, and storage of all samples for various clinical trials.

Guaranteed seamless laboratory operations through analysis of current laboratory processes and creation of innovative strategies.

Led the execution and documentation of required regular maintenance activities on biological safety cabinet, centrifuges, and emergency medical equipment.

Held responsibility in implementing and verifying SOPs for laboratory operations, including centrifuge and class II BSC usage and maintenance, as well as urine pregnancy tests.

Collected and processed all laboratory specimens for all volunteer samples across all ongoing clinical studies.

Strictly complied with Occupational Safety and Health Administration (OSHA) and Walter Reed Army Institute of Research (WRAIR) safety guidelines.

Ensured proper collection, packing, and disposal activities for biohazard materials.

Completed proper calibration of all equipment to secure data integrity of laboratory procedures.

Oversaw the chain of custody documentation and confidentiality for human samples transportation.

Clinical Trials Laboratory Research Assistant/Coordinator United States Army, Silver Spring, MD 2012–2014

Organized comprehensive blood collection schedules based on the inherent need of partnering scientist.

Carried out all enlisted volunteer duties, such as specimen’s acquisition and processing, as well as equipment and apparatus security for multiple clinical trials.

Acted as the focal point of contact between researchers and volunteers to achieve strict confidentiality of volunteer information and operational safety.

Functioned as an effective government purchase credit card holder for 15 months focused on purchasing and securing supplies for the Translational Medicine Branch.

Teamed up with 5 different partners and more than 50 volunteers in the establishment of blood collection guidelines, which allowed easy access to samples and specimens as needed.

Earlier Position Held:

Medical Laboratory Specialist Trainee United States Army, Fort Sam Houston, TX and Fort Knox, KY

OTHER EXPERIENCE

Rank-Senior Airman United States Air Force Reserve, Various Locations 2015–2018

Customer Care Representative Ryla Teleservices, Kennesaw, GA 2010

Business Analyst, ERISA Compliance Hartford Retirement Services, Atlanta, GA 2008–2009

Participant Services Representative Princeton Retirement Group, Atlanta, GA 2006–2008

Division Leader Primerica Financial Services, Cartersville, GA 2002–2006

EDUCATION

Associate of Science in Clinical Laboratory Science, 2012 George Washington University, Washington, DC

Bachelor of Science in Mathematics, 2008 Kennesaw State University, Kennesaw, GA

PROFESSIONAL DEVELOPMENT

American Society for Clinical Pathology (ASCP) Certified Medical Laboratory Technician, 2011–Present

Good Clinical Practice (GCP) Certification, 2020–Present

United States Army Advanced Individual Training

PROFESSIONAL AFFILIATION

American Society for Clinical Pathology (ASCP)

AWARD

Army Commendation Medal

Contact this candidate