Sterile Pharmacist (USP )

Job Description

Job Description

Key Responsibilities

Sterile Compounding Oversight:

• Supervise the preparation and verification of CSPs, including IV solutions, injections, and ophthalmic preparations.
• Ensure compliance with USP <797> , USP <800> (if applicable), and FDA guidelines.

Quality Assurance and Compliance:

• Conduct regular audits of cleanroom practices, compounding records, and environmental monitoring logs.
• Oversee media fill tests, gloved fingertip tests, and other required competency assessments for sterile technicians.
• Review and approve Master Formulation Records and Compounding Records for CSPs.

Cleanroom Maintenance:

• Monitor cleanroom operations, including routine cleaning, environmental conditions, and equipment functionality.
• Ensure proper use of personal protective equipment (PPE) and aseptic techniques by all staff.

Training and Development:

• Train pharmacy technicians in sterile compounding techniques and regulatory compliance.
• Stay up-to-date on changes to USP <797> and other regulatory standards, and implement updates as needed.

Documentation and Record-Keeping:

• Maintain accurate records of all sterile compounding activities, including batch logs, validation records, and quality control tests.
• Ensure proper labeling and storage of CSPs, including beyond-use dating (BUD) and storage conditions.

Inventory Management:

• Manage inventory of sterile compounding materials, including raw ingredients and cleanroom supplies.
• Monitor stock levels to ensure uninterrupted operations.

Patient and Physician Support:

• Provide consultation to patients and healthcare providers on CSPs and related therapies.
• Address inquiries about dosage, administration, and potential side effects of compounded medications.

Qualifications

Education and Licensure:

• Doctor of Pharmacy (PharmD) degree from an accredited institution.
• Current pharmacist license in AL or eligibility for licensure.

Experience:

• Previous experience in sterile compounding under USP <797> standards is required.
• Knowledge of USP <800> standards for hazardous drug compounding is preferred.

Skills and Attributes:

• Strong attention to detail and commitment to quality assurance.
• Excellent organizational and problem-solving skills.
• Ability to work collaboratively in a team-oriented environment.
• Proficient in using compounding software and maintaining detailed records.