СШАManager, Sterile Operations
4 нед. назад
СШАSeniorOnsite
usp 797usp 800aseptic technique
Responsible for oversight of sterile compounding and compliance with USP 797 and 800 standards in a cleanroom environment.
Обязанности
- The Manager, Sterile Operations, will be responsible for the oversight of sterile compounding in their designated Modular Cleanroom Shift, 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 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
Требования
- 3+ years of pharmacy experience that includes sterile compounding exposure, preferably compounding from nonsterile starting components.
- Doctor of Pharmacy (Pharm D), with active license in the State of Ohio.
- 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
Будет плюсом
- Board Certification in Sterile Compounding or willingness to complete in the first year of employment.
- Designated Person or Assigned Trainer in sterile compounding pharmacy.
- 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).
- 3+ years in a managerial role over Pharmacists, Technicians, and pharmacy support personnel
Условия
- Competitive salary & comprehensive health benefits including medical, dental & vision
- Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
- Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
- It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
- To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement .
Другое
- Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
- Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.