Non-Sterile Pharmacist (USP )

Job Description

Job Description

Non-Sterile Compounding Oversight

• Supervise the preparation and verification of non-sterile compounded preparations (e.g., oral suspensions, pastes, powders, capsules, and topicals).
• Ensure all formulations follow USP <795> standards, BRD protocols, and state/federal regulatory guidelines.
• Review and approve Master Formulation Records (MFRs) and Compounding Records for accuracy and compliance.

Quality Assurance & Compliance

• Conduct routine audits of compounding processes, technician procedures, and documentation.
• Ensure compliance with USP <795> and FDA guidelines for non-sterile compounding, including labeling, storage, and packaging requirements.
• Oversee technician competencies, including onboarding, training validation, and periodic performance checks.

Workflow & Team Leadership

• Coordinate day-to-day workflow for non-sterile operations to ensure timely and accurate production.
• Delegate and manage technician schedules to maintain productivity and balance workload.
• Act as a liaison between non-sterile compounding, fulfillment, and customer service to resolve production issues efficiently.

Inventory & Supply Chain Management

• Manage raw material inventory and ensure proper storage, labeling, and rotation (FIFO).
• Collaborate with purchasing and receiving teams to maintain optimal stock levels and avoid production delays.
• Ensure availability of required equipment and supplies, including scales, mixing devices, and packaging materials.

Documentation & Record Keeping

• Maintain thorough, accurate, and compliant records for all compounded preparations.
• Monitor beyond-use dating (BUD) and ensure proper documentation for product testing and stability.
• Support inspection readiness by keeping records audit-ready and organized.

Training & Professional Development

• Train new and existing technicians on USP <795> procedures, formulation techniques, and safety protocols.
• Stay current with updates to compounding regulations and implement required changes across the team.
• Promote a culture of continuous improvement and quality throughout the compounding team.

Cross-Departmental Collaboration

• Communicate regularly with the Pharmacist-in-Charge, Sales, and Fulfillment teams to prioritize product demands and handle escalated inquiries.
• Partner with QA/QC teams to ensure all non-sterile compounded products meet quality standards before release.

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 <795> 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.