Senior Consultant
Sandy Hook, Ct
Directly responsible for designing, developing and implementing quality control programs to support medical device and pharmaceutical industry clients in meeting requirements established by ISO 9001, Quality System Regulations (QSR), ISO 13485, and GxPs. Worked with numerous clients to design, implement, and evaluate internal audit programs to measure system compliance and identify meaningful corrective action (CAPA) activities. Audit activities included the assessment of vendors and contract organizations as well as internal operations. Worked with clients to establish corporate policies and procedures for the control of documentation and reporting systems compliant with GxP quality system requirements. Activities included configuration management, SOP development, and the evaluation, selection, and implementation of computer based systems for document control and quality record reporting and maintenance. Assisted clients in establishing proper laboratory practices and methodologies in accordance with quality system requirements. Assisted clients in identifying, installing, and using proper laboratory information management systems (LIMS) software to ensure compliance to 21 CFR 11. Developed and conducted presentations to client personnel. These presentations included management overviews to executive management as well as technical and compliance briefings to the engineering and quality staffs.ADDITIONAL RELATED EXPERIENCE:VITRO CORPORATION, Rockville, MDCorporate Program Manager Hardware / Software Quality AssuranceBERETTA USA, Accokeek, MDManager, Quality Assurance LaboratoryWESTINGHOUSE ELECTRIC CORPORATION, Lima, OHManager, Metrology and Quality Assurance LabsWESTINGHOUSE ELECTRIC CORPORATION, Hunt Valley, MDOperations Test Engineer