Sterile Compounding Pharmacist Operations Manager
Sterile Compounding
The Sterile Pharmacist Operations Manager will perform and lead all aspects of high-risk/category 3 level sterile compounding, ensuring all preparations meet required standards.
Supervision
Supervise sterile compounding technicians, provide mentorship, training, and ensure compliance with SOPs and USP Chapter 797 and 800 standards.
Compliance
Ensure all sterile compounding activities comply with USP Chapter 797 and 800 standards and company SOPs.
Aseptic Processes
- Lead and ensure aseptic processes, including garbing, hand-hygiene, cleaning, environmental monitoring, aseptic technique, and verification testing, are performed accurately.
Quality Assurance
Maintain standards for strength, quality, purity, integrity, sterility, and endotoxin content in all compounded preparations.
Operational Management
Lead all aspects of day-to-day operations of the sterile compounding pharmacy, ensuring efficiency and adherence to regulatory requirements.
Inventory Management
Assist in maintaining inventory and supplies.
Collaboration
Work closely with the Head Compounding Pharmacist, Quality Assurance Team, and other pharmacy staff to ensure efficient and safe compounding practices in the compounding facility as business demands.
Knowledge
- In-depth knowledge of the accurate use of compounding equipment in the cleanroom and non-sterile lab vital for both sterile and non-sterile compounds.
- SOP Compliance: Ability to follow all company SOPs.
- Guideline Familiarity: Familiarity with USP 797, 800, and upcoming guidelines for the preparation of compounded medications.
- Aseptic Technique: Prior training/experience in aseptic technique and extemporaneous compounding, with high-risk sterile compounding experience preferred.
- Inventory Skills: Ability to maintain inventory, supplies, and handle ordering/price negotiating from wholesalers is a plus.
Licensing
- Pennsylvania Licensed Pharmacist with formal training in sterile compounding or equivalent experience.
- 3+ years of experience.
Education Requirements
- BS or PharmD.
Physical Requirements
- Compounding may be exposed to chemicals used in the preparation of compounds (some are classified as hazardous and/or toxic by the National Institute for Safety and Health and special safety precautions must be taken when working with these chemicals).
- Have visual acuity, color vision, peripheral vision, and depth perception.
- Be able to lift at least 25 pounds and be able to stand for long periods of time.
- Work in various positions and locations such as sitting, standing, squatting, kneeling, reaching, and walking.
- Wear required PPE when required and use hands to handle, control, or feel objects, tools, or controls.