belinda barnes

* Conducted routine and non routine testing for WFI, RO, and steam. * Specialized in conductivity, pH, Total Organic Carbon, Bioburden, Kinetic Turbidimetric analysis, raw material testing, compressed gases, BI indicator testing, viable air testing and steam collection. * Performed environmental monitoring and airflow visualization studies in aseptic areas of manufacturing. * Assisted with investigations for Alert/Action level reports and discrepancy event reports. * Facilitated general audits of manufacturing personnel aseptic technique and laboratory audits in compliance with GMP and GLP. * Validated multiple processes in production manufacturing areas. Utilized multiple databases for sample accountability. * Executed training for all associates and assistants in sample testing, collection in accordance to USP, JP and EU requirements.

* Reviews and approves multiple batch production records, standard operating procedures, test records, and associated documentation for GMP compliance from beginning to end of the product process. * Collaborates with ICON and Regulatory Affairs for product registration and manufacturing contracts that support release of final container shipments for all regions of the world. * Responds to market product withdrawal, recall, and surveillance according to FDA regulations. * Evaluates protocols, change controls, validations, and revisions detrimental to product release. * Audit and review weekly, monthly, quarterly reports and excel logs. * Functions actively with all departments inside and outside the infrastructure to meet deadlines implemented by company demand. * Utilizes SAP to ensure transfer movements, results recording, check shelf life specifications, lot and history traces to support batch approval.