Develops and initiates biocompatibility assessment studies for medical devices by inspecting sponsor-provided documents and manufacturing blueprints to ensure they meet ISO, GLP, and industry standards for regulatory submissions.Completed NAMSA eLearning ISO 10993 Series 1 training certification.Schedules and attends meetings with sponsors to go over any difficulties with their medical devices, discuss their clinical trial plans, and answer questions about medical device regulations.Manages high-priority projects with tight deadlines, often being praised for breaking complex projects down into manageable parts and preemptively implementing solutions to any potential risks with testing.Took the initiative to train and guide 5 new hires while also managing a large project load.Assisted OPS department in shipping test articles and extracts using FedEx.

Communicates between study directors, lab management, and clients to develop and initiate projects for pre-clinical biocompatibility testing.Develops protocols to ensure that testing information is correct, accurate, and has clear instructions. Assists with initiating standard biocompatibility studies including communicating with the client, passing on study-specific information to the Study Director or lab team, and performing administrative tasks like protocol binder development, label creation, and printing study-specific forms.Receives, releases, and labels study articles for testing and communicates with applicable departments on the disposal or return of study articles.Maintains documentation for projects by entering all necessary information into the company’s online SaaS while also reviewing physical documentation for errors.Communicates with the Accounts Receivable department to ensure studies may start and deliverables may be uploaded to the online portal for Sponsor receipt.Communicates between the Scientific department and the clients to ensure study timelines are met.Maintains knowledge of applicable Standard Operating Procedures (SOPs), GLP, and other domestic and foreign regulations/standards in order to assist clients in reaching their testing goals.Revamped organizational system for weekly department tasks and large, long-standing projects to better accommodate a larger team.Developed guides on the protocol development process with some frequently asked questions for new clients to use as a reference.

Balanced working in tandem between the drug testing lab and LIMS System to run and complete analytical data analysis on up to 700 clinical patient samples per day, with each sample testing for 180+ analytes.Evaluated raw data for accuracy; recognized and corrected errors and unusual results, and interpreted results to produce a final report.Managed time and priorities effectively to complete review of standard patient data and more precise confirmational assaysCommunicated with other departments and management to organize priorities, answer questions, and respond to requests in a timely manner.Performed regular quality tests and maintenance on LCMS instruments to recognize testing errors and troubleshoot problems with test results.Evaluated, used, and prepared lab reagents, standards, and quality controls according to SOPs.Maintained accurate records for all lab tests and equipment including instrument logs, maintenance logs, disinfection logs, assay SOPs, and chains of custody.Assisted other departments in locating, verifying, and extracting patient samples for advanced testing.

Operated Hamilton Star machines to extract up to 1,300 medical samples daily onto 96 well-plates through pre-analytical processing.Prepared and organized aliquots of up to 200 samples a day by hand for advanced clinical testingFollowed all SOPs and maintained documentation of clinical tests.Participated in Continuing Education opportunities.Assisted other departments in locating, verifying, and extracting patient samples for advanced testing.Received and checked in sample shipments using LIMS and ensured they went to the right department.

Aided victims of domestic and sexual violence at the domestic violence shelter by maintaining security and protecting private information.Assisted clients in obtaining resources and services to help them with financial assistance, legal assistance, medical services, and housing.Responded quickly to phone calls to the Emergency 24-Hour Helpline, assisting in crisis intervention and screening potential applicants to the shelter.Communicated clearly and effectively with clients, donors, government agencies, and follow mandated reporting and government regulation requirements.Organized client information and documentation along with various administrative tasks to assist advocates in providing individual support.Traveled to local hospitals and medical service providers as needed to meet with victims of abuse and offer services and support.Participated in community outreach in order to connect with potential donors and volunteers for the shelter.

Accepted and review deliveries of plants and landscaping materials for the Garden DepartmentTracked customer orders and ensured items were ready for customer pick-up and deliverySought out by coworkers to assist customers in finding products and answering questions