Aseptic Core Monitor

The Aseptic Core Monitor reports to the Quality Assurance Manager. This role works closely with Operations personnel, Environmental Monitoring, and the Aseptic Quality Specialist during all aseptic production activities. The Aseptic Core Monitor will be responsible for completing aseptic audits and addressing any quality-related questions during manufacturing. The Aseptic Core Monitor will work closely with the AQ Specialist to address all unplanned events within the controlled areas that may require remediation or interventions to be executed. The Aseptic Core Monitor will work alongside production to return events to a controlled state through communication and coordination of multiple departments to reduce the impact on production’s schedule.Responsibilities:Ability to identify and report on QA events related to the maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.Responsible for timely and accurate process review of batch records and QA checks within the manufacturing process.The Aseptic Core Monitor’s primary role is actively coaching, auditing, and communicating within Aseptic Processing Areas for the majority of the shift. Must maintain aseptic gown training and be an extension of quality and training within the aseptic areas to monitor and reinforce best aseptic practices.Assist in generating procedures related to Aseptic Quality functions/activities.Maintain compliance with FDA 503B and cGMP guidelines/state and federal laws.Assist in developing policies and procedures related to Aseptic Quality.Promptly communicate with Operations regarding personnel aseptic techniques and behaviors, complaints, product issues/variances.Gather, organize & analyze data to develop solutions & alternative methods of proceeding compliantly.Assist CAPA teams and other project teams in the development of action plans and implementation of deliverables.Conduct periodic internal reviews or audits to ensure that procedures are followed.Lead and organize remediation activities from day-to-day unplanned events or shutdown activities.Lead, coach, and mentor personnel on aseptic techniques and practices when executing smoke studies, audits during manufacturing activities. Correct and communicate proper aseptic technique when needed and communicate with supervisors as needed on corrected behaviors.Requirements:High School Diploma with a BS/BA degree or 3 years of manufacturing experience.Minimum 2 years of pharmaceutical experience with experience in a quality/compliance function.Ability to multi-task, effectively communicate, and demonstrate critical thinking.Oversight of operations with a focus on Sterility Assurance.Knowledge of QMS and CAPA related tools or systems is preferred.Environmental monitoring, Aseptic Processing, or production audit experience is preferred.Experience with inspections and inspection readiness activities preferred.We offer a dynamic environment where talent and ambition can develop to their fullest. We have an open and informal organizational culture, where individuals need to have strong motivation and the ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and the ability to be part of an international leader in an expanding industry.

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