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hims & hers · 3 weeks ago

Manager, Sterile Operations

Gilbert, Arizona

Full-time

Onsite

Mid, Senior Level

4+ years exp

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. The Manager, Sterile Operations, will be responsible for the oversight of sterile compounding in their designated Modular Cleanroom Shift, ensuring compliance with USP 797, 800, and other applicable chapters to compound safe and effective sterile preparations.

Health CareLifestyleMen'sWellnessWomen's

Responsibilities

You may serve as one of the Designated Persons for USP 797 and USP 800 when assigned by your leadership

Maintain and enforce proper aseptic technique and cleanroom standards

Provide training and supervision to compounding personnel

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 the use of equipment for 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

Supervise sterile compounding supervising pharmacists who are responsible for day-to-day compounding execution

Work 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) for personnel, quality, compliance, and regulatory matters

Willingness to complete external training as required

Qualification

Sterile compoundingUSP 797 complianceUSP 800 complianceCertified Pharmacy TechnicianPharm DManagerial experienceQuality assuranceAseptic techniqueEnvironmental monitoringRegulatory complianceWindows proficiencySafety equipment usageLeadership

Required

3+ years of pharmacy experience that includes sterile compounding exposure, preferably compounding from nonsterile starting components

Current registration as a Certified Pharmacy Technician in the State of Arizona AND National Certification (CPhT) OR Doctor of Pharmacy (Pharm D), with active license in the State of Arizona

Certified Compounded Sterile Preparation Technician® (CSPT®) or willingness to complete in the first year of employment

Deep working knowledge of USP 797 and 800 requirements and best practices

Awareness of state and federal pharmacy laws, rules, and regulations related to the practice of pharmacy

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

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