Sterile Compounding Pharmacist M-F 9am-5:30pm

Melbourne Pharma; Melbourne (FL); Presencial; USD 110 000 - 150 000; Tempo integral

Resumo da oferta

Melbourne Pharma seeks an experienced Sterile Compounding Pharmacist to oversee both sterile and nonsterile compounding operations in Melbourne, FL. You will ensure compliance with USP , , and , supervise staff, review and release compounded preparations, and uphold the highest standards of quality and safety.

The ideal candidate will have extensive sterile compounding knowledge, strong leadership, and the ability to enforce SOPs while driving a culture of continuous improvement and regulatory

Qualificações

• Graduate of an accredited College of Pharmacy.
• Active Florida pharmacist license in good standing.
• Prior sterile compounding experience required.
• Strong working knowledge of USP <797>, USP <800>, and USP <795>.
• Ability to supervise and enforce SOPs and regulatory requirements.
• Excellent documentation, organizational, and communication skills.

Responsabilidades

• Oversee daily sterile compounding operations in compliance with USP 797, state regulations, and SOPs.
• Provide pharmacist oversight for nonsterile compounding per USP 800 and USP 795.
• Supervise pharmacy technicians and compounding personnel to ensure aseptic techniques.
• Perform final verification and release of compounded products.
• Collaborate with QA to maintain regulatory compliance and inspection readiness.

Conhecimentos

Sterile compounding expertise

Leadership

Regulatory compliance

Documentation

Communication

Formação académica

Graduate of an accredited College of Pharmacy

Active FL Pharmacist License

Ferramentas

USP 797/800/795 knowledge

Descrição da oferta de emprego

We are seeking an experienced, highly motivated Sterile Compounding Pharmacist to oversee and support both sterile and nonsterile compounding operations. This position is responsible for ensuring compliance with USP <797>, USP <800> and USP <795> standards, supervising compounding personnel, reviewing and releasing compounded preparations, and maintaining the highest level of quality, safety, and regulatory compliance.

The ideal candidate will have extensive knowledge of sterile compounding practices, strong leadership skills, and the ability to enforce Standard Operating Procedures (SOPs) while driving a culture of quality and continuous improvement.

Essential Duties and Responsibilities

• Oversee daily sterile compounding operations in compliance with USP <797>, state regulations, and company SOPs.
• Provide pharmacist oversight for nonsterile compounding activities in accordance with UPS <800> and USP <795> as needed.
• Supervise pharmacy technicians and compounding personnel to ensure proper aseptic and compounding techniques.
• Perform final verification and release of compounded sterile and nonsterile preparations.
• Conduct and document 100% visual vial inspections for sterile products, including inspection for particulate matter, solution clarity, fill volume, container integrity, cosmetic defects, and labeling accuracy.
• Review and approve all completed batch records and quality control documentation prior to product release as needed.
• Ensure compliance with environmental monitoring, cleaning, gowning, and cleanroom maintenance requirements.
• Oversee receipt, inspection, and approval of APIs, excipients, packaging components, and other compounding materials.
• Work with quality department to train, qualify, and evaluate pharmacy personnel on USP <797>, USP <795>, aseptic technique, and SOP compliance.
• Collaborate with Quality Assurance to maintain regulatory compliance and inspection readiness.
• Assist with inventory management, purchasing, and material control activities.
• Support internal audits and inspections by regulatory agencies and accreditation organizations.
• Ensure all compounding activities are performed safely, accurately, and in accordance with established procedures.
• Perform all other duties as assigned.

Qualifications

• Graduate of an accredited College of Pharmacy.
• Clear and active pharmacy license in good standing issued by the State of FL Board of Pharmacy.
• Previous sterile compounding experience required.
• Strong working knowledge of USP <797> Sterile Compounding requirements.
• Strong working knowledge of USP <795> Nonsterile Compounding requirements.
• Experience with batch compounding operations preferred.
• Thorough understanding of aseptic technique, cleanroom operations, and contamination control principles.
• Experience performing final product verification and vial inspections for compounded sterile preparations.
• Ability to follow and enforce SOPs and regulatory requirements.
• Excellent documentation, organizational, and communication skills.
• Strong leadership and problem-solving abilities.

Physical Requirements

• Ability to stand and work for extended periods.
• Ability to wear cleanroom gowning and personal protective equipment (PPE).
• Ability to lift up to 25 pounds.
• Ability to perform detailed visual inspections and tasks requiring precision and attention to detail.
• Demonstrate excellent attendance and punctuality.
• Maintain the highest standards of professionalism, quality, and patient safety.
• Foster a culture of compliance, accountability, and continuous improvement.
• Ensure all sterile and nonsterile compounded products meet established quality standards prior to release.

Join our team and play a key role in delivering high-quality compounded medications while maintaining the highest standards of safety, quality, and regulatory compliance.