Sandy Rubio, Consultant

 

 Sandy Rubio was educated at Northern Illinois University and received a Bachelors of Science in Biology in 1988. Upon graduating, she went to Silliker Laboratories in Chicago Heights, IL, where she performed testing on foodborne pathogens, assisted in food poisoning investigations, and trained new employees in rapid techniques for detection of food pathogens. In 1991, Ms. Rubio moved on to Fujisawa U.S.A. where she was instrumental in setting up and maintaining the Biological Indicator Laboratory. After performing IQ, OQ, and PQs for all equipment in the laboratory and writing a complete set up of operating procedures for the laboratory, she produced and qualified biological indicators that were used to support the validation and routine monitoring of sterilization cycles used in FUSA manufacturing facilites. During her time at Fujisawa, she published a number of papers with the PDA Journal of Pharmaceutical Science and Technology on the effects of various environmental conditions on biological indicators.

Sandy then moved on to Pharmaceutical Systems, Inc. in 1995. At PSI she was responsible for the manufacture and qualification of custom biological indicators for pharmaceutical and medical device clients using moist and dry heat, EO, and gas plasma sterilization processes. She provided technical support for BI positive investigations and R&D studies for clients using unique sterilization process applications. In 2001, she joined Compliance Software Solutions, Inc. where she was responsible for performing simulated-use trials on new software modules and the quarterly validation of their environmental monitoring software products.

In 2005, Sandy signed on at MicroWorks, Inc. as a project consultant. Her experience with us includes performing client laboratory audits to identify microbiology test method and equipment validation gaps. She developed client-specific Validaton Master Plans to bring laboratories into compliance and developed and validated test methods for bioburden, sterility, endotoxin, and surface sampling to support those efforts. She has also assembled environmental monitoring summaries for clients that include statistical analysis of Alert and Action Limit s, evaluating/trending environmental monitoring data excursions, and evaluating personnel and material flow. She is responsible for writing and executing protocols and SOP's for pharmaceutical companies, auditing microbiological testing laboratories and manufacturing facilities and support of client projects.

E-mail: Sandy_Rubio@MWIConsulting.com