769 million. That's how many lives are touched by Novartis products globally. And, while we're proud of that fact, in this world of digital and technological transformation, we must ask ourselves this: how can we continue to improve and extend even more people's lives? The Microbiology Expert, Quality Control is responsible for implementing, maintaining QC microbiology of Quality Control testing for Product and Environment in compliance with GMP/FDA regulations, AAA standard operating procedures and Product specifications.
General responsibilities will include but are not limited to the following: * Supports QC Manager in all planning, coordination, and execution of QC microbiology related activities. * Acts as QC Single Point of Contact for all microbiology related activities, including projects for the Millburn, NJ facility. Primary contact for technical troubleshooting and compliance for microbiology related matters. * Ensures that all microbiological aspects of manufacturing and testing of products comply with GMP/FDA regulations and AAA guidelines, and are conducted per local SOPs * Along with Quality Assurance, ensures training compliance in manufacturing and QC area related to microbiology, aseptic behavior, gowning, and sterility assurance principles. * As Subject Matter Expert, manage critical microbiological issues, e.g. EM excursion in class A, sterility failures, media fill failures * Responsible for all technical aspects and procedures related to microbiology quality control testing readiness including QC reagents and materials management, cleaning and maintenance activities, sample management and QC testing. * Responsible for the oversight on Manufacturing for QC sampling activities for sterility testing and microbiological testing. * Review Product testing and Environmental Monitoring for microbiology QC testing and reporting of the results. Escalate in case of non-conformances and deviations and manage these quality incidents as per AAA procedures. * Performs deviation investigations, OOS/OOT investigations, CAPAs and Change Controls. Liaise with QA to ensure compliance activities are performed timely. * Prepare EM reports, assess trends and make recommendation. * Responsible for establishing regular meetings and proper KPIs, in the areas of EM and aseptic expert team. SPOC for Millburn AAA aseptic network team. * Responsible for continuous improvements in microbiology at site, and in aseptic practices; develop site personnel in microbiology and aseptic practices.