-Conduct routine testing, including: growth promotion, sterility, stability, pH, and cosmetic appearance, on finished goods, per ISO, FDA, and USP/EP/JP standards.- Minimum inhibitory concentration for finished goods.- Conduct environmental monitoring of facility, process waters, and production lines.- Microbiological testing and identification for environmental monitoring, finished product, and customer investigations, utilizing Previ and Vitek 2.- Adhere to cGMP and cGLP standards- Initiation, execution, and investigation of nonconformance and OOS deviations- Create and revise standards of protocol - Utilizing LIMS, SAP, Minitab and Microsoft Office applications for collection, management, and trending of quality control data.- Participation in CAPA activities- Grow and maintain stock cultures of bacteria and fungi- Certified as a Lean Leader through bioMerieux Lean Six Sigma

-Conduct routine testing, including: growth promotion, sterility, stability, pH, and cosmetic appearance, on finished goods, per ISO, FDA, and USP standards.-Minimum inhibitory concentration for finished goods.-Conduct environmental monitoring of facility, process waters, and production lines.- Microbiological testing and identification for environmental monitoring, finished product, and customer investigations, utilizing Previ and Vitek 2.- Adhere to cGMP and cGLP standards- Initiation and execution of NCMR and OOS deviations- Utilizing LIMS, SAP, Minitab and Microsoft Office applications for collection, management, and trending of quality control data.- Participation in CAPA activities- Grow and maintain stock cultures of bacteria and fungi

- Tutoring specializing in microbiology, biology, chemistry, and mathematics.

-Perform routine microbiological testing on pharmaceutical, cosmetic, and antimicrobial products including, but not limited to: - Testing for antimicrobial effectiveness on hydrophobic surfaces (JIS Z2810, ISO 22196) - Time-kill studies (ASTM E2180, ASTM D5590, ASTM 1153) - Minimum Inhibitory Concentration (MIC) - USP <61>, <62> for non-sterile pharmaceutical, microbial enumeration testing - USP <71> for sterile, pharmaceutical grade products - USP <51> followed to challenge the antimicrobial effectiveness of products. - USP <85> endotoxin testing - FDA-BAM for microbial analysis of cosmetics - Testing suitability of methodology and method validation. - Other bioburden testing -Routing laboratory cleaning and maintenance-Quality assurance; SOP revision-BSL-3 safety

• Conducted microbial testing per FDA-BAM on finished product, environmental samples, and raw material. • USP <61>, <62>, and <85> protocols utilized for pharmaceutical products and processes. • Performed RT-PCR for Salmonella spp. and Listeria spp. using GENE-UP• Entered and release testing for production batch records, using SAP.• Utilized 5S strategies for maximum efficiency of workflow and organization.• Plant and process sampling of water, corn syrup, HEPA filters, and finished product.• Communicated with external plants and internal departments regarding testing needs and issues.

¨ Support cleaning procedures and utilities validation¨ Coordinate activities focused on the characterization and control of process and facility bioburden¨ Work with multiple departments to design and conduct studies to assess the impact of change to products, processes, methods or equipment and/or re-validate/re-qualify as necessary.. USP <61>, <62>¨ Capture, trend, and analyze method and process performance metrics to maintain control and to identify opportunities for improvement¨ Generate and establish analytical methods and new analytical technologies and oversee their transfer to the microbiology laboratory¨ Trouble-shoot and optimize existing methods as needed¨ Provide microbiological expertise as a project team member

My responsibilities include growing and maintaining bacterial cultures, sampling soil and water for analysis, preparing media for bacterial cultivation, DNA extraction, polymerase chain reaction, bioinformatic analysis, and routine laboratory tasks.

Administrative and clerical roles to a high paced laboratory, with cGLP and cGDP demands. The laboratory specializes in at-home blood testing for HIV, Hepatitis C, cholesterol, and others.