JOB SUMMARY
Under the direct supervision of the Sterile Compounding Supervisor, the Cleanroom Lead works in a Cleanroom environment. While maintaining model standard of sterile Compounding, the Cleanroom Lead will be responsible for supervising and managing all cleanroom personnel (cleanroom technicians) and activities within the cleanroom. The Lead will provide continuous positive leadership and guidance to all cleanroom technicians on proper aseptic practices, cleanroom behaviors and production workflow.
The Lead will be required to work in a fast-paced environment, minimal supervision, delegate tasks and be able to make quick decisions. The Cleanroom Lead will ensure compounding is performed based on standard SOP including environmental monitoring. The Cleanroom Lead may help prepare medications, complete sterile compounding of medication, perform sterility testing and maintains the Cleanroom and equipment, and
monitor inventory.
DUTIES AND RESPONSIBILITIES
• Monitor daily production, prioritize, and manage batch admixing, perform in-process checks inside the cleanroom, supervise, and ensure all cleanroom personnel are complying to proper aseptic technique and cleanroom behaviors, continuously providing constructive feedback to all cleanroom technicians, maintain direct contact with on-site pharmacist(s), Sterile Compounding Supervisor, Registered tech(s) and Department manager, provide leadership and mentoring to all cleanroom technicians.
• Perform aseptic admixing activities, (Antibiotic batch, Anesthetics, Narcotics, Chemotherapy) while ensuring full compliance with SOP’s and applicable aseptic technique practices. Select, teardown and stage production components according to written documentation, receive and store raw material and label, package, and store final product, assemble and label shipping containers, print and collate production and
shipping documentation.
• Perform and record validation and environmental and technique microbiological monitoring.
• Demonstrate excellent organizational skills.
• Maintain model standard of sterile Compounding in the Cleanroom
• Maintain daily environmental monitoring.
• Retain Cleanroom standards through cleaning and disinfection protocols.
• Perform daily (AM and PM), weekly and monthly cleaning of the clean and Anteroom.
• Perform housekeeping of cleanroom and adjust areas (check, storage, change room & Lab)
• Perform stocking/restocking of medication and supplies as per SOPs.
• Perform glove fingertip sampling/ Media fill testing as required.
• Follow the operational workflow and assigned tasks.
• Assist the Sterile Compounding Supervisor or designate in maintaining federal, provincial, and local laws, accrediting body standards, and Policies and Procedures (P&Ps).
• Assist the Sterile Compounding Supervisor or designate in performing physical count of medication and supplies, as needed.
• Assist the Sterile Compounding Supervisor or designate in inventory management.
• Performs IV admixtures sterility testing in accordance with policy, maintains appropriate documentation.
• Assists the Sterile Compounding Supervisor or designate in preparing required infusion supplies for delivery of medication.
• Prepares sterile parenteral following appropriate aseptic technique and obtaining required checks by Pharmacists or designate and appropriate assembly of drugs and supplies by matching codes and quantities from the compounding document, correct labelling of product, checking the final product for the absence of particulate matter and container integrity and ensuring compounding product gets matched to the right delivery just prior to shipping.
• Conducts quality control and sterility testing
• Assists the Pharmacist or designate in preparing compounding sheets for the preparation of medication.
• Complete the daily, weekly, monthly, and occasional logs in timely manner.
• Assists the Pharmacist or designate in the preparation and labeling of medications as allowed by law.
• Other duties, as assigned.
REPORTING RELATIONSHIPS
The Cleanroom Lead reports directly to Sterile compounding Supervisor. The Cleanroom Lead also liaises with the BSRx employees as appropriate.
