GEORGEE MATHEW
West Fargo
Summary
Resourceful Supervisor trained in resolution of critical issues within time-sensitive environment with successful track record of building and maintaining talented teams. Highly organized, energetic and versatile leader committed to continuous improvements. Proven history of motivating staff to work together to achieve targets.
Overview
10
10
years of professional experience
Work History
Associate Research Compliance Specialist
Sanford Health
Fargo
05.2025 - Current
- Ensure compliance with federal and state laws, including Conditions of Participation, Code of Federal Regulations (CFR), Good Clinical Practice (GCP) standards, and all regulations governing human subjects research
- Review, prepare, and submit clinical trial documentation for new studies, annual continuing reviews, amendments, addendums, and updates to the Institutional Review Board (IRB)
- Maintain accurate and organized regulatory records, tracking clinical trial volume and documentation to support sponsor, cooperative group, and FDA audits or inspections
- Organize and maintain up-to-date study materials, including protocols, investigator brochures, and informed consent forms, ensuring accurate information is available to physicians and study staff to promote patient safety
- Communicate directly with sponsors, study teams, and IRB coordinators regarding study-specific document modifications, clarifications, and IRB-requested revisions
- Support audit readiness by ensuring documentation consistency, version control, and adherence to IRB and regulatory timelines
- Collaborate with research staff to ensure proper implementation of approved protocol requirements and compliance with institutional and regulatory standards
Quality Control Analyst
Aldevron
Fargo
08.2023 - 05.2025
- Perform routine and non-routine Microbiological and Analytical Microbiology sampling, which includes environmental monitoring
- Experienced in testing protocols and procedures to ensure product compliance with industry standard
- Experienced in ISO7/EU GMP Grade C gowning and cleanroom behaviors
- Expert knowledge in GDP, GLP and current good manufacturing practices (cGMP)
- Knowledge and experience in QMS such as MasterControl for updating official documentation
- Knowledge in conducting root cause analysis and deviation investigations
- Responsible for reviewing and approving test results against established limits and specifications
- Experienced in using and troubleshooting systems and equipment such as LIMS, Growth Direct System (GDS), Endosafe nexgen-MCS systems, Sievers TOC analyzers, ApexZ3 particle counters, and SAS air samplers
Laboratory Technician (QC)
Agropur
Lake Norden
08.2022 - 07.2023
- Responsible for supporting production by analyzing a variety of samples using different test methods; performing microbiological and physical tests on raw material, in process products and finished products
- Daily tasks include the receipt of samples, determining methods by reviewing procedures and specifications, testing samples (reporting any abnormal reactions to laboratory leadership), documenting, and reporting of results, cleaning, and stocking the work area
- Responsible for the daily maintenance of laboratory equipment and performing quality control checks
- Follow work instructions set forth by Test Procedures (TPs), Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs) and Master Sanitation Schedules (MSS) and Good Laboratory Practices (GLP)
Senior Student Patrol Supervisor
South Dakota State University Police Department
Brookings
08.2016 - 05.2022
- Build schedule for the student officers and train new student officers on policies, and procedures
- Conduct a patrol of campus property and assist officers in service along with emergency calls
- Successfully perform under high pressure environments by upholding laws/rules and de-escalating tense situations while staying professional and unbiased around all personality types
Student Manager
South Dakota State University State Tech
Brookings
03.2016 - 12.2021
- Hire students, coordinate schedules, and supervise high-level event operations
- Create training curriculum and hands-on-exercises
- Conducted both personalized and large group trainings for team members
- Provide great customer service to every client by helping the customers feel at ease and explain complex systems in a simple personable way
- Able to use critical thinking to learn, troubleshoot and resolve complex systems quickly
- Assign daily tasks to employees to increase efficiency and teach accountability
- Manage $250,000 equipment inventory and discuss purchasing decisions with the operations manager
Lab Assistant
South Dakota State University Plant Science
Brookings
11.2018 - 03.2019
- Independently conducted and assisted in conducting assigned research activities on soybean and sunflower diseases with directions provided by the primary investigator (Species of Fusarium Causing Root Rot of Soybean in South Dakota: Characterization, Pathogenicity, and Interaction with Heterodera Glycines (sdstate.edu))
- Clean and bag seeds while working under time constrains to meet schedules by precise time management skills
Education
Bachelor of Science - Microbiology And Biotechnology
South Dakota State University
Brookings, SD 01.2016 - 05/2022
Skills
- FDA regulations
- Document management systems
- CGMP
- GCP
- GDP
- Team management
- SOP development
- Root cause analysis
- Training and development
- Human resources management
Languages
- English
- Malayalam
- Hindi
- Tamil
Timeline
Associate Research Compliance Specialist
Sanford Health
05.2025 - Current
Quality Control Analyst
Aldevron
08.2023 - 05.2025
Laboratory Technician (QC)
Agropur
08.2022 - 07.2023
Lab Assistant
South Dakota State University Plant Science
11.2018 - 03.2019
Senior Student Patrol Supervisor
South Dakota State University Police Department
08.2016 - 05.2022
Student Manager
South Dakota State University State Tech
03.2016 - 12.2021
Bachelor of Science - Microbiology And Biotechnology
South Dakota State University
01.2016 - 05/2022