Throughout the past eleven years I have been actively involved in the applied microbiology and molecular biology fields with recent emphasis on research and development.

At my current position with Steris Corporation, I am responsible for the technical coordination of developmental research projects to support FDA 510(k) submission of disinfection/sterilization equipment, chemistries, and biological indicators. I am responsible for planning, conducting, and supervising developmental product validation activities such as product qualification, process validation testing, analysis of test data, and the generation of supporting documentation such as standard operating procedures, test protocols, and technical reports. The coordination of contract research while fostering collaborative relationships with industry thought leaders has been part of my current job function. My additional accomplishments include the implementation of new laboratory technologies, such as real time PCR, and successfully implementing a database to streamline the storage and retrieval of full-text scientific references. Writing and implementing design controls for the development of new products, such as marketing, device/design, & qualification test specifications, along with design history files, are also some of my past accomplishments. These experiences have given me an applied understanding of the importance that interdepartmental cooperation has on competently completing many of these functions in a timely manner.  

Previously at Loctite Corporations Quality Assurance Department, I was responsible for building a comprehensive, state-of -the-art microbiology laboratory and performing the daily laboratory activities to support the manufacturing process. Implementation of the clean-in-process, environmental monitoring, statistical process control, and the microbiology awareness training programs were some of my accomplishments. Additionally, I oversaw the microbiological validation of outside vendor sanitization procedures and qualified outside laboratories for microbiological testing when necessary. Internally, I supported the regulatory inspections from organizations such as ISO, UL, and the FDA. I was an active member of the Material Review Board, the Hand Cleaner Technology Team, and the Validation Teams for the introduction of Resinol/PMS manufacturing and rapid microbiological testing (ATP Bioluminescence). Responsibility for the microbiology/chemistry laboratories capital expenditure, maintaining/purchasing of laboratory supplies and hiring/managing temporary laboratory help were also part of my duties.

My experience has allowed for a sound understanding of good laboratory and manufacturing practices (GLP/GMP) in accordance with FDAs Quality Systems Regulations (QSR). Working with various regulatory guidelines (FDA, EPA, CDC, CEN, TGA, AFNOR, Canadian, etc.) has given me a broad understanding of accomplishing regulatory compliance. My extensive laboratory experiences including analytical, physical, typical chemical and applied microbiology and molecular biology testing methods used in a manufacturing and/or R&D setting has allowed me a more thorough understanding of the product development process. 

Tony A. Rook, B.S.