• Interprets and understands relevant laws, regulations, and standards and provides guidance, instruction, and enforcement of cGMP compliance.• Reviews, and approves SOPs, validation documents, and relevant quality records (deviation, CAPA, change controls, etc.) for accuracy, consistency, and compliance with relevant federal and state regulations.• Develops/Authors technical documents including Quality System records (Deviations, CAPA, Change Control, etc.), SOPs, work instructions, validation documents (VP, RA, FRS, URS, CS, DDS, IOQ, PQ, UAT, Reports, etc.), etc. in compliance to applicable laws, standards, and internal procedures.

 Provided support for FDA 483 Remediation: o Perform risk-based validation of Environmental Trending Spreadsheets.o Perform gap analysis of aseptic technique and sterile compounding processes to improve internal auditing processes. o Contributed to the following CAPA Teams (Data Integrity, Aseptic Technique, Spreadsheet Validation, Sterility Testing). o Developed and implemented Data integrity controls and training. Plan, coordinate, and organize daily activities of Microbiology Laboratory and environmental monitoring program for an 8,000 sq. ft cleanroom facility consisting of ISO class 5, 7, and 8 rooms.  Ensures all microbiological and sterility testing is completed according to specification to ensure on time release of products/devices.  Performs CAPA investigations, root cause analysis, gap analysis for microbial excursions and customer complaints. Participates in internal and external audits to ensure regulatory compliance. Responsible for the final microbiological release of products/devices.  Oversees microbiology related process validation activities.  Trains and proactively develop education standards for laboratory personnel  Performs validation of new CSP products for endotoxin testing utilizing the Endoscan Endosafe assay performed on the Biotek Endoscan reader Planned and executed temperature mapping studies of pallet racking for raw material storage and finished goods inventory in GMP areas. Mapped temperature and relative humidity using VL-2000 data loggers Prepared qualification reports including all raw data of all temperature mapping studies of controlled temperature equipment including requalifications and new installations.

• Perform environmental monitoring in an aseptic cleanrooms per USP on a daily basis• Perform sterility testing of finished product for all batches compounded in aseptic processing areas• Perform CAPA investigations, root cause analysis, gap analysis for microbial excursions and customer complaints• Perform internal audits of processes to insure FDA compliance• Perform batch release of finished product per acceptable quality limits• Perform endotoxin testing of finished product per USP chapter <85>• Implemented temperature mapping in GMP areas

Oversee a department of 12 technicians, providing a leadership role when supervisor was absent. Perform quantitative and qualitative testing for salmonella, listeria, and staphylococcus species, bacillus, and other species of microorganisms.