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The Microbiologist is responsible for performing microbiological tests on media, pharmaceutical products and raw materials in compliance with current GMP regulations, procedures and systems. Also responsible for supporting Environmental monitoring in aseptic environment and method validation, transfer, and improvements
Your responsibilities include, but are not limited to:
* Perform and support Microbiological/Sterility testing, Environmental Monitoring testing and investigation and change control activities (deviations, OOS, OOE, OOT, CAPAs, trending). * Ensure that QC testing is properly conducted and documented for all performed activities, with emphasis on Data Integrity. * Support and execute the microbiological program. * Author, review and support procedures, investigations, corrective, and preventive actions, change controls, complaints and training as it relates to microbiological testing and environmental monitoring. * Support transfer projects, validation studies, method improvement and new equipment qualifications. * Support health authorities' inspections and internal audits of QC. Ensure quality control area is inspection ready. * Support Quality Assurance, Quality Control and AS&T as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity