Lead Compounding Pharmacist, Sterile - Day Shift

About the Role:

The Lead Sterile Compounding Pharmacist, will be responsible for the oversight of sterile compounding operations in their designated Modular Cleanroom Suite, as well as acting as a subject matter expert in sterile compounding. You will ensure strict compliance with USP 797, 800 (and other applicable chapters) in order to compound safe and effective sterile preparations in accordance with state and federal law.

Shift: 6:00am-6:00pm, rotating 3-2-2-3 schedule

• Act as Designated Person at the discretion of the Sterile Compounding Manager, Pharmacist for USP 797 and USP 800

• Maintain and enforce proper aseptic technique and cleanroom standards

• Provide training and supervision to compounding and support personnel performing aseptic manipulations, pre-sterilization 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 to used in sterile compounding operations and monitor the compounding environment in conjunction with the maintenance team

• Oversee cleanroom workflow, daily logs and environmental monitoring procedures in conjunction with quality

• Manage sterile compounding pharmacists, technicians, and/or support personnel who are responsible for day-to-day compounding execution.

• 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 800 and applicable laws

• When required, wear all personal protective equipment (PPE)

• Coordinate with the Pharmacist-in-charge (PIC) and/or Sterile Compounding Manager, Pharmacist for personnel, quality, compliance and regulatory matters

• Willingness to complete external training as required

• 3 years of pharmacist experience

• 1+ years of pharmacist experience with experience in sterile compounding preferably compounding from nonsterile starting components Doctor of Pharmacy (Pharm
  
  D) or Bachelor’s degree in Pharmacy from an accredited institution

• Active Pharmacist License in State of employment (OH or AZ)

• 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

• Served in leadership role

• 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

• Experience compounding from non sterile starting components.

• Familiarity with electronic documentation systems and compounding workflow software

• Experience with regulatory inspections (e.g., State Board, FDA, NABP).

• 1+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel

• Competitive salary & comprehensive…