Compounding Pharmacist, Sterile

Hims & Hers•Gilbert, AZ

About The Position

We are seeking a Sterile Compounding Pharmacist to oversee sterile compounding operations within a modular cleanroom suite. In this role, you will act as a subject matter expert, ensuring compliance with USP <797>, <800>, 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.

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
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.

Nice To Haves

Experience compounding from non sterile starting components.
Familiarity with electronic documentation systems and compounding workflow software.

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 <800> and applicable laws
When required, wear all personal protective equipment (PPE)
Coordinate with the Pharmacist-in-charge (PIC), Sterile Compounding Manager, Pharmacist, and/or Lead Sterile Compounding Pharmacist for personnel, quality, compliance and regulatory matters.
Willingness to complete external training as 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