Lead Compounding Pharmacist, Sterile

About the role

We are seeking a Sterile Compounding Pharmacist to oversee sterile compounding operations within a modular cleanroom suite.

Responsibilities

• 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.
• Willingness to complete external training as required.

Requirements

• 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 (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.
• Ability to work flexible shift times.
• Proficiency in Windows based computer systems.
• Ability to undergo respirator fit testing - Full beards or a lot of facial hair may prevent a proper seal for the respirator.
• Knowledgeable and empathetic leader to in-person pharmacist and technician teams.
• Able to lift at least 25 pounds with or without reasonable accommodation.
• Able to stand for long 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.
• Maintain a clean and sanitary work environment as mandated by the FDA’s rules and regulations.

Qualifications

• Compounding from non-sterile starting components.
• Familiarity with electronic documentation systems and compounding workflow software.

Skills

• Compliance with USP 797 and 800 requirements.
• State and federal pharmacy laws, rules and regulations.
• Windows based computer systems.
• Respirator fit testing.
• Personal Protective Equipment (PPE).
• Electronic documentation systems.
• Compounding workflow software.

Benefits

• Competitive salary & comprehensive health benefits including medical, dental & vision.

Pay

Details TBD.

Schedule

Day Shift: Monday through Thursday, 7am-530p.