To obtain a position as a Clinical Research Associate that will enable me to use my strong interpersonal skills, verbal and written communication skills, organization skills and to utilize my 8 years of technical experiences in quality, process improvement and research and development. I have a strong technical background in quality assurance, quality control and finishing and product development. The ability to provide process improvement and research and development on new products in laboratory setting and manufacturing process. Experience with FDA regulated pharmaceutical/medical device companies with the understanding and knowledge of GMP and GLP with good documentation practices with a strong regulatory knowledge of GCP.
Laboratory: BET (Kinetic and Gel Clot), Container ClosureMCC (Micro scale Combustion Calorimeter), Integrity Challenge Testing, EnvironmentalThermal Protective Performance of Material for Monitoring, Equipment Calibration, Growth Promotion, Protective Clothing for hot surface content-TPP, Isolator Technology, MethodFlame Resistance of Textile-Vertical Char Development, Writing Standard Procedures(SOPs), Microbial Enumeration,Falling Pendulum (Elmendorf) Apparatus, Microbial ID Systems (i.e. VITEK II Compact),Colorfastness Testing, Milnor Industrial Washing Particulate Matter, Performance Qualification- Procedures, Dry-Time Testing, Sample Dye-jet, Equipment, Project Planning, Sterility TestingAir Permeability, Fabric Coating (Direct, Membrane Filtration), ELISA testing, Water System Testing, Acid Digestion, NMR, TLC, Viscosity, Rotavapor |
- Collaborate with Senior Research Chemist on flame retardant experimental design.
- Manage multiple projects using project management skills.
- Analyze problems and implement solutions using critical thinking skills and focused improvement methods from data collected.
- Generate, document and report data in an efficient manner using Patentsafe.
- Communicate information about experiments accurately and effectively to management and team members.
- Work independently or under supervision.
- Effectively communicate with members of a team to achieve team and individual project targets and timeliness.
- Lead team members to solve problems using a logical, systematic, and sequential approach using data collected.
- Determined the bioburden level of incoming raw materials, components and in-process solutions.
- Identification of microbial isolates using VITEK 2.
- Responsible for cultures and biological indicator solutions used for plant validation and product development studies.
- Perform environmental monitoring (total air particulate, viable air and surfaces) of the plant controlled work zones.
- Water Sampling and testing for TOC/Conductivity and Bioburden.
- Performed microbiological testing bulk manufacturing, pre-sterile products, and environmental monitoring and bioburden.
- Troubleshoot laboratory issues in sterility testing and out of limits reports.
- Performed technical review of laboratory data, analytical test methods and SOP.
- Determined preventative and corrective actions for laboratory investigations.
- Identified microorganisms isolate from environmental, personnel, and water monitoring sampling using VITEK 2 Compact.
- Performed aseptic techniques, serial dilutions, plate counting, sampling and plating techniques.
- Performed bioburden testing, RODAC testing, viable air particle testing and airborne particle testing.
- Conducted training and supervise 2 team members on various laboratory techniques.
- Performed membrane filtration Bacteriostasis/Fungistasis testing.
- Performed environmental monitoring testing in a GMP clean room environment.
- Performed microbiological testing and sampling for water, bulk manufacturing, pre-sterile products, disinfectants and finished products and biological indicators.
- Operated VHP and isolators.
- Wrote and contribute to the content of Standard Operations Procedures, Technical Reports and Gap Analysis.
- Internal auditing using ISO standards.
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School Attended
- South Carolina State University
- Liberty University
Job Titles Held:
- Research Technical Specialist
- Qualitative Fit Test Trainer, Pyro Leg Expert/Trainer
- Microbiology Laboratory Technician III
Degrees
- Bachelor of Science
- Master of Business Administration
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