Sterile Compounding Pharmacist

The Sterile Compounding Pharmacist will oversee sterile compounding operations within a modular cleanroom suite. In this role, you will act as a subject matter expert, ensuring compliance with USP , , and other applicable guidelines. You will supervise personnel and maintain the highest standards for compounding safety, quality, and compliance in accordance with state and federal regulations.

• Direct shift sterile compounding activities in compliance with USP 797 and USP 800.
• Maintain and enforce proper aseptic technique and cleanroom standards
• Provide training and technical guidance to compounding and support personnel performing aseptic manipulations, presterilization activities, visual inspection, labeling/packaging, materials/equipment preparation and movement.
• Perform and accurately document compounding procedures, quality assurance/quality control checks, of compounded sterile preparations
• Review and approve materials prior to use in sterile compounding
• Oversee use of equipment used in sterile compounding operations to used in sterile compounding operations in conjunction with the maintenance team
• Oversee cleanroom workflow, daily logs and environmental monitoring procedures in conjunction with quality.
• Work closely with R&D Teams on the development and scale up of new compounded sterile preparations.
• Follow all safety, USP, BOP, and internal guidelines for the preparation of compounded medications.
• Maintain a safety-first mindset and ensure precautions are taken in all compounding activities in accordance with USP 797 including when working with hazardous chemicals in accordance with USP and applicable laws.
• Coordinate with the Pharmacist-in-charge (PIC), Sterile Compounding Manager, Pharmacist, and/or Lead Sterile Compounding Pharmacist for personnel, quality, compliance and regulatory matters.
• Pharmacist experience with experience in sterile compounding preferably compounding from nonsterile starting components.
• Doctor of Pharmacy (Pharm
  
  D).
• Active Pharmacist License in State of employment (OH)
• Proficiency in USP 797 and 800 requirements and best practices.
• Current knowledge of state and federal pharmacy laws, rules and regulations related to the practice of pharmacy
• Ability to work flexible shift times
• Proficiency in Windows based computer systems
• Must be able to undergo respirator fit testing – Full beards or a lot of facial hair may prevent a proper seal for the respirator
• Must be a knowledgeable and empathetic leader to in-person pharmacist and technician teams
• Must be able to lift at least 25 pounds with or without reasonable accommodation
• Must be able to stand for long periods of time
• Pharmacists will work in a variety of positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking; for prolonged periods of time
• Must be able to wear required compounding safety equipment for long periods of time when required.
• Maintain all security and privacy rules regarding the use and handling of protected health information (PHI) in compliance with federal and state HIPAA regulations.
• Follow all state and pharmacy regulations and rules as designated by the required State Board of Pharmacy and the Food and Drug Administration (FDA).
• Maintain a clean and sanitary work environment as mandated by the FDA’s rules and regulations.