Über die Tätigkeit

Summary:

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. Aseptic Core Monitor will be responsible for completing aseptic audits and addressing any quality related questions during manufacturing. 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. Aseptic Core Monitor will work alongside production to return event to a controlled state through communication and coordination of multiple departments to reduce impact of production’s schedule.

Responsibilities:

· Ability to identify and report on QA events related to 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.

· Aseptic Core Monitor’s primary role is actively coaching, auditing, and communicating within Aseptic Processing Areas for the majority of 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.

· Assists in developing policies and procedures related to Aseptic Quality.

· Promptly communicates 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 study, audits during manufacturing activities. Correcting and communicating proper aseptic technique when needed and communicating with supervisors as needed on corrected behaviors.