Senior Manager,Sterile Operations Operations Job Gilbert area,Arizona USA,Healthcare

Senior Manager, Sterile Operations Oversee sterile compounding operations to ensure USP compliance and scalable, efficient production.

Location:

Gilbert, Arizona, United States

Job Tags:
Operations

About

The Role

The Senior Manager, Sterile Operations will be responsible for the oversight of sterile compounding 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.

You

Will:

Serve as one of the Designated Persons for USP 797 and USP 800.

Maintain and enforce proper aseptic technique and cleanroom standards

Provide training and supervision to compounding personnel including direct supervision of 8 shift managers and indirect supervision of 100+ pharmacy technicians and pharmacists.

Drive daily/weekly/month performance for Safety, Quality and Financial performance metrics

Maintain training requirements to support the execution of sterile compounding including hand hygiene, gowning and media fill qualifications.

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 for sterile compounding operations and monitor the compliant operation of the compounding environment 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

Work closely with the Technical Services team to create and implement projects that result in cost savings and process improvements that elevate quality standards and throughput capabilities.

Partner with quality to perform risk assessments, conduct investigations, and design and implement remediation and risk mitigation strategies

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

You Have:

5+ years of pharmacist experience, at least 3+ sterile compounding preferably compounding from nonsterile starting components.
Board Certification in Sterile Compounding or willingness to complete in the first year of employment.
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
3+ 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

Preferred Qualifications:

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).
5+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel

Our Benefits (there are more but here are some highlights):

Competitive salary & equity compensation for full-time roles
Unlimited PTO, company holidays, and quarterly mental health days
Comprehensive health benefits including medical, dental & vision, and parental leave
Employee Stock Purchase Program (ESPP)
401k benefits with employer matching…


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Senior Manager, Sterile Operations Operations