Result-focused microbiology manager leading microbiology laboratories. Experience in aseptic processing, microbiology, chemistry, environmental monitoring, sterilization (E-Beam, gamma, ETO, dry heat, and steam) aseptic gowning, environmental monitoring, utility system (WFI, RO, drinking/in-process, compressed air & nitrogen) monitoring, microbial method validation, microbial data trend reporting, strategic planning, organizational development, and teambuilding. Strong understanding of industry practice and regulatory trends pertaining to the quality control of drug/ophthalmics products. Successful leader in leading the operations of microbiology laboratories/contamination control and demonstrating effectiveness in regulatory compliance/ contamination control. Comprehensive knowledge and interpretation of cGMP/cGLP, USDA, NRC, EMEA, EPA regulations. Maintains positive relationships and network effectively across sites and organizations.
•Improved Laboratory Compliance at Akorn Somerset, Covidien Healthcare (Formerly Tyco & Mallinckrodt), Chesapeake Biological Labs, Schwarz Pharma, Sanofi Animal Health & Pitman-Moore by addressing all compliance risks and former regulatory observations; no critical or major observation found any of these sites.
•Developed/Validated Various Microbiology Methods that included: direct inoculation/membrane filtration sterility test; Gel Clot/Kinetic Turbimetric/Kinetic Colorimetric Endotoxin Testing; Pour Plate/Membrane Filtration Bioburden, MicroSeq/Vitek Identification System, Gas Monitoring Via SAS/RCS Air Sampler; Environmental Monitoring Performance Qualification; Microbial Monitoring of Drinking and WFI Water; selection and purchase of Novatek LIMS, CLIMET software, Non-Viable Spreadsheet, SAS/SMA Air Sampler, Class 10,000 Packaging/Inspection Tents, Grid Mapping Clean Rooms, UV Goggle Cabinet, Media Fills, Incubators, Milliflex, Water Systems, Water Baths, implemented an environmental monitoring program, Validated microbiology equipment (AutoTurb, Water Bath, Sample Dilutor) and methods (Turbidimetric Assays, TLC, Frozen Microorganisms, using Karl Fischer to calculate moisture), etc.
•Oversaw/Developed Corporate Microbiology Conference for Entire Pharmaceutical Sector; monthly EM trends results to the site at Covidien Healthcare. Provided quarterly trends for the site at CBL and Akorn.
•Served on a number of teams: change control, cleaning validations, LIMS, EM & Utility Monitoring, Kaizens, Kepner-Triegoe, raw material, 21 CFR Part 11 Team, CDS (Leader), Facility Qualification, Water System (Shared Leadership), QC Data Review (Leader); statistics/disinfection/Lab Improvements; Microbiology Advisement Committee & Water Review Committee
•Laboratory Information Management System (LIMS) - (Implementation/Training); Chromatography Data Acquisition System (Selection and Implementation)
•Oversaw the purchase, installation and validation of a number of rapid microbiology systems: BioControl, Celsis ATP, Bactometer, Microseq/Vitek Microbial Identification
•Participated in the reorganization and workflow of the Elanco Finals Workgroup and Warner Lambert Quality Group
•Established the Laboratory Automation Board that implemented rapid methods for both labs (data acquisition system, color spectrophotometer method, real time monitoring of equipment, Bactometer (plate counts, disinfectant efficacy, antibiotic assay), integrating LIMS with Lab Systems, evaluated the use of connecting refrigerators/freezers/incubators to a LabWatch, ATP swab method, Biotest 1-2, Millipore ATP pathogen screen.
Department manager (Environmental Monitoring, Microbiology Testing, and Raw Material Sampling) for ophthalmic products in tube and bottle applications. Lead contamination control over ISO 5, 6, 7 & 8 Clean Rooms using viable and non-viable monitoring test methods. Oversaw the quarterly trending of environmental monitoring data.
Administered, Advised, Analyzed, Applied, Attended, Chaired, Charted, Collected, Conducted, Coordinated, Designed, Developed, Directed, Discovered, Established, Evaluated, Experimented, Explored, Facilitated, Guided, Headed, Implemented, Initiated, Instituted, Instructed, Investigated, Lead, Lectured, Managed, Measured, Monitored, Prepared, Presented, Produced, Published, Researched, Reviewed, Sampled, Tested, Wrote, Adapted
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