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 GCP regulations and guidelines. Interact directly with management to monitor facilities, equipment, personnel, methods, practices, policies, procedures, records and controls for conformance with appropriate regulatory standards, SOPs, test methods, and/or approved protocols for bioanalytical studies and supportive operations.Over 30 years experience in Good Laboratory Practices (GLP). Certified Registered Quality Assurance Professional (RQAP). Bachelor’s degree in chemistry and with 20 years of analytical and bioanalytical laboratory experience and over10 years experience in quality assurance.

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 regulations and guidelines and OECD GLP standards for submission to US and non-US regulatory agencies.Extensive experience in providing high quality GLP and quality systems training. Provided over 100+ instruction-led face-to-face training sessions and online webinar training sessions to participants in the pharmaceutical, biotech, medical device, academic/university, specialty chemical, and other life science industries.

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 annual refresher training for employees, classroom training, writing/administration of electronic testing system, system administration of corporate personnel training documentation, writing of SOPs, supervision of regulatory Archives. Developed/validated database systems for personnel training documentation, controlled access chain of custody/inventory tracking, and regulatory Archive documentation tracking. Served on the 21CFR11 task force working on electronic records/signature regulatory requirements

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 active clients, preparing bid proposals and coordinating studies. Responsibilities also included identifying end-user requirements for Laboratory Information Management System (LIMS) applications and assistance in the design/development of LIMS applications. Developed training material and conducted training for employees on these and other application systems.

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 pesticides in biological and agricultural matrices for analysis by LC-MS/MS for FDA/EPA studies for pharmaceutical, animal health and agricultural businesses. Designed and developed a bioanalytical sample tracking database system.

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 chemistry projects involving development/validation of analytical methods - extraction, partitioning, derivatization, cleanup and gas chromatographic quantitation techniques, and approval of data. Generated cost projections/manpower estimates; and provided consultation/ technical support to clients. Wrote/translated technical procedures/reports in both Spanish and English. Trained laboratory personnel in government agricultural lab in Panama.

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.