Implementing strategies for the on-boarding of new hires. Reducing down time through competency based learning models. Using my experience to develop strong cross functional relationships within our campus under our shared cost center. Reshaping training throughout multiple departments to better fit our evolving business needs.

Usual microbiological testing formats. ELISA, Bioburden, Endotoxin, etc. Also utilizing Trackwise to initiate Lab investigations and revising SOP’s. Gained valuable experience in more leadership aspects of working in a major pharmaceutical laboratory.

Performing the following assays:Endotoxin Bioburden TOCConductivityELISA

In my current position at SeraCare Life Sciences, I am gaining a working knowledge of ISO 9001 & ISO 13845 quality system methods. Also I have further utilized my ability to communicate technical problems in a clear concise manner. While there, I have worked in conditions that included the handling of infectious and non-infectious human plasma, serum and hazardous chemicals. I helped to continue ensuring department adherence to company Standard Operating Procedures, along with regulatory agency and customer requirements. My current testing includes: performing manual ELISA, quantitative PCR, particle agglutination, Bioburden, Western Blot and automated chemistry tests on samples. I routinely review test data and related documents for accuracy and validity, while helping to revise and review Standard Operating Procedures. I ensure testing equipment is monitored and calibrated according to established schedule and process and by doing so have gained further experience in assisting with the development and implementation of corrective actions in response to internal and external audit. Also I perform environmental monitoring of manufacturing clean rooms as needed.

Worked in the RI Branch as director where I guided the laboratory to an ISO accreditation with only 3 minor deficiencies. Also in my tenure as director, we participated in 3 tests submitted to us by the American Proficiency Institute in which we scored in 95% or higher in all test methods. Implemented the usage of our Laboratory Inventory Management System (LIMS) and oversaw the transition of our laboratory from a standard 40 hour 9 am - 5 pm schedule Monday through Friday to a 24 hour 7 day a week operation. Responsible for results that were submitted to the USDA & FDA. Assisted a new laboratory director in the Omaha branch in both IEH Standard Operating Procedures and preparation for external & internal audits.