Highly experienced in lean manufacturing processes with over 4 years of industry expertise and a certification as a manufacturing practitioner. More than 3 years of GMP experience in the bio-pharma and biotechnology sectors, along with over 1 year of basic quality control skills including inspection and document review. Well-versed in FDA principles and familiar with Out of Specifications (OOS) protocols. Proficient in utilizing software for manufacturing and quality processes. Educated in basic engineering and chemistry, holding a certification in graphics. Demonstrating over 4 years of experience in 2D and 3D computer-aided design software. Skilled at enhancing Standard Operating Procedures (SOPs) through the use of guides and charts. Certified in ISO class 7 standards and experienced in aseptic techniques, cryo-preservation techniques, as well as possessing a strong understanding of cellular culture techniques and processes. Adept at investigating, writing, and comprehending deviations, while also well-versed in Corrective and Preventive Actions (CAPA).
Helped with process improvements to reduce waste.
Identified errors within systems to help create better flow of manufacturing process.
Collaborated with team to help increase safety.