Celeste Rose Email & Phone Number

Cleveland, OH, US

Lead in the development, implementation, and oversight of processes and procedures to improve and support the technical quality and integrity of study-related deliverables for BDS and its clients. Serve as primary Archivist, Document Coordinator, and Training Coordinator.

Tampa/St. Petersburg, Florida Area

Senior level QA Professional, reporting to the Chief Executive Officer, to lead in the development and implementation of the BDS Quality Assurance program to support management in the assurance that the facilities, equipment, personnel, methods, practices, records and controls for bioanalytical laboratory studies are in conformance with applicable GLP and.

Over 30 years experience in Good Laboratory Practices (GLP). Certified Registered Quality Assurance Professional (RQAP). Bachelor’s degree in chemistry and over 20 years of analytical and bioanalytical laboratory experience. Experience “at-the-bench” with over 10 years experience as a Study Director conducting GLP studies in compliance with EPA and FDA.

Senior Training Specialist/ Senior Quality Assurance Specialist 2000 – February 2002 Dept of Quality Assurance/Regulatory AffairsDeveloped, implemented and maintained corporate training programs, to meet regulatory requirements and contribute to Quality System operations. Primary responsibilities included regulatory training of new hires, GLP/GMP - related.

Responsibilities included technical writing of dossier summary reports for submission to regulatory agencies (US EPA, Canadian EPA, Europe OECD). Represented Ricerca at Animal Health Institute (AHI) meetings as a scientific representative. Assisted with the development of new business in the animal health/pharmaceutical areas by contacting potential and.

Solely responsible for set-up of Bioanalytical Services sample prep laboratory, including the creation of the department Standard Operating Procedures (SOPs), qualification of equipment, and training of personnel. Responsibilities included supervision of lab personnel in the development/ validation of methods for extraction/ SPE clean-up of drugs and.

Study Director/Analytical Project Manager for pesticide residue studies involving crops/soil/water. Wrote protocol/ report documents (~50 studies in total) for submission to US EPA, Canadian EPA and European regulatory agencies. Familiar with general field agricultural practices. Team Leader responsible for supervision of 2 - 10 people on agricultural.

Conducted structural determination of organic compounds using 13C and proton NMR, IR, UV-Vis and fluorescence. Also conducted analyses using ICP, AA, GC, Electron microscopy and conventional wet analysis techniques.