Cleanroom Coordinator

Overview

The Cleanroom Coordinator will prepare and control individual pharmaceutical compounds based on prescriptions with the aim of ensuring that the patient receives the correct medication.

• Schedule weekly production based on personnel, qualifications, available components, and facility capacity
• Revise weekly production schedule as needed due to changes in personnel, equipment, inventory, cleanroom status, or additional batch requests
• Coordinate duties of staff during a facility shutdown or annual inventory days
• Early terminate batches as needed and complete documentation
• Address component and API issues as they arise by reaching out to the responsible personnel
• Create production orders for semi-finished goods
• Create production orders and estimate the goods within AX
• Process daily picklists for Aseptic Support Personnel to wipe into the cleanroom
• Work with QA for timely batch issuance, batch rescheduling, and batch cancellation
• Review components and equipment needed for future production
• Create transfer orders to and from FSS East to support production
• Coordinate with other departments for ordering and releasing production components
• Assist with collecting data and writing production events and deviations
• Review batch records and identify errors prior to submission to QA
• Assist in keeping the warehouse organized and clean
• Cycle count in warehouse to ensure the inventory is accurate
• Create counting journals and adjust inventory as necessary
• Scrap expired and wasted components
• Assist cleanroom with equipment needs
• Participate in cleanroom technician interviews
• Help manager with process improvement projects
• Assist wipe in of components occasionally
• Follow standard operating procedures in completion of assigned tasks
• Clock in and out for each scheduled shift in a timely manner