Quality Assurance department head for Merial, Inc., Avian Biologics. I manage 12 staff members in three work streams: Release, Quality Systems and TechnicalIn the RAP role, I am responsible for assuring Manufacturing and Quality Control compliance with various agency regulations. In this role, I authorize release of raw materials, active ingredients or antigenic components, and final products. The raw material management includes quality third party activity management which… Show more Quality Assurance department head for Merial, Inc., Avian Biologics. I manage 12 staff members in three work streams: Release, Quality Systems and TechnicalIn the RAP role, I am responsible for assuring Manufacturing and Quality Control compliance with various agency regulations. In this role, I authorize release of raw materials, active ingredients or antigenic components, and final products. The raw material management includes quality third party activity management which entails ensuring vendor approval, raw material testing and auditing of those third parties.I currently manage 5 staff members that assist with the quality review of manufacturing, inspection and release of the raw materials, intermediate antigenic components and final products along with any required quality documentation such as Certificates of Analysis, Certificates of Origin and other various shipping, quality or regulatory associated documents. My team and I support and liaise with Manufacturing, Quality Control, Packaging,Customer Service, Research/Development and Distribution departments. I review and approve internal protocols, compile annual Product Quality Reviews, and assist with audits and complaints.Additionally, I am responsible for managing two other teams in QA (7 staff members)- quality systems management along with validations, calibrations environmental and water monitoring. Show less

Reponsible for Quality Control testing in comformance with USDA regulations or other agency regulations for animal health Biological Manufacturing.In this role, I managed 20 staff members. The management of the QC Merial Select Berlin, MD was conducted romotely with weekly phone conferences and made at least quarterly trips to that location to assist staff.

I joined Select Labs in Nov 1984 as a QC Lab Technician. In this role my responsbilities were employing 9 CFR Chapter 113 testing, such as sterility, Mycoplasma, Salmonella, Avian Leukosis, extraneous pathogens and extraneous agents, safety, hemagglutination testing, hemadsorption, identity, and titrations. Around 1988, I became an Assistant QC/QA Manager and worked in the Research and Development (R/D) department. During this time, I was responsible for QC testing in conformance with… Show more I joined Select Labs in Nov 1984 as a QC Lab Technician. In this role my responsbilities were employing 9 CFR Chapter 113 testing, such as sterility, Mycoplasma, Salmonella, Avian Leukosis, extraneous pathogens and extraneous agents, safety, hemagglutination testing, hemadsorption, identity, and titrations. Around 1988, I became an Assistant QC/QA Manager and worked in the Research and Development (R/D) department. During this time, I was responsible for QC testing in conformance with regulations, release of antigens and final product and managed 8 employees. While working with the R/D department, I was responsible for the development of recombinant virus isolates into master seed including full testing of those seeds. The QC responsbilities included management and testing for the following test types: sterility, Mycoplasma, Salmonella, Avian Leukosis, extraneous pathogens and extraneous agents, safety, hemagglutination testing, hemadsorption, FA, VN, HI, identity, Elisa, AGP, plate agglutination, and titrations. From 1989-1992, I was responsible for the development and management of Specific Pathogen Free (SPF) testing lab for Merial Select's SPF Avian (Egg) Farm.In 1995 my management role expanded to QC Manager and in 1996-97 the role encompassed managing 20 staff members total for the Gainesville, GA facility and the Berlin, MD facility. The management of the QC Merial Select Berlin, MD was conducted remotely from 1996-2012 with weekly phone conferences and made at least quarterly trips to that location to assist staff. During this time period 1996-1998, I was responsible for the development of quality control testing lab in Melbourne, Australia with a joint venture production lab. Show less

I was repsonsible for conducting quality control testing of live and inactivated avian vaccines. This included media preparation, chick embryo fibroblast cell culture production, 9 CFR Chapter 113 sterility testing, mycoplasma testing, Salmonella testing, Avian Leukosis testing, extraneous pathogens, extraneous agents testing, safety testing, titration and identity testing, Elisa testing, and assisted with R/D testing as needed.