Quality: CAPA, Nonconformance, Risk Analysis Tools (PHA, FMEA), Root Cause Analysis (5 why, Ishikawa, Fault Tree Analysis), Technical Writing, Supplier Auditing, Form Building, Reviewing/Auditing Production Process Data.
Microbiology: Environmental monitoring (using Rodac and settling plates), Trending and Microscopy, Aseptic technique, Algal cell culturing, Hemocytometry.
Chemistry: GIRMS (Gas Isotope Mass Spectrometry), Spectrophotometry, Water Activity , PCR, Media Preparation and Filtration.
Oversaw the production of Cairn's GEBT (Gastric Emptying Breath Test) kit produced under 21 CFR 820, and managed the production of Cairn Diagnostics' diagnostic substrate. Managed the supply chain of various subcontracted processes (5 total) that go into manufacturing the drug product component of the GEBT. Audited suppliers' ability to satisfy company requirements, and worked with suppliers to implement supplier corrective actions when needed. Developed production records and specification documents, and provided periodic summary reports to MWER regarding production or supplier issues.
Oversaw the production of Cairn Diagnostics' diagnostic substrate, a 13-Carbon labeled algal biomass produced under 21 CFR 211. Worked directly with COO to establish production schedules and generate pro forma models to keep up with sales demands. Day to day activities: performed microbial and environmental monitoring of production areas, tracked and trended production process data, reviewed maintenance and calibration records, trained staff on aseptic technique, and mantained inventories.
Co-Curriculum Chair, Master of Science: Professional Science (MSPS) Program Advisory Board, Middle Tennessee State University. The MSPS advisory board is comprised of industry professionals and faculty members in the fields of biotechnology, bio-statistics, HealthCare management, engineering management, and actuarial science. As the Co-Curriculum chair, I am responsible for providing direct industry level input to faculty and administration staff responsible for establishing the curricula of the different MSPS programs to ensure that the courses offered are applicable to the demands of industry.
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