Sterile Compounding Pharmacist M-F 9am-5:30pm
Melbourne Pharma
Job Summary
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.
Work Expectations
- 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.
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience:
- Sterile compounding: 3 years (Required)
License/Certification:
- Florida Licensed Pharmacist (Required)
Work Location: In person
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