Compounding Pharmacist

Compounding Pharmacist

AVEVA DRUG DELIVERY SYSTEMS INC - 3.7

Tamarac, FL Job Details Full-time 1 day ago Qualifications Registered Pharmacist (RPh) Document review (document control) Pharmaceutical regulatory compliance Licensed Pharmacist (State-Specific) Licensed Pharmacist Batch records Environmental monitoring State and federal pharmacy laws Healthcare compliance

Full Job Description About Us:

Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary:

The Compounding Pharmacist will be responsible for the direct supervision of pharmaceutical production activities within a 503(b) outsourcing facility. The role involves ensuring compliance with state and federal regulations, Good Manufacturing Practices (GMP), and internal procedures to ensure the aseptic and terminally sterilized production of pharmaceuticals. The Pharmacist will work collaboratively with production, quality, and compliance teams to oversee all aspects of compounding and manufacturing operations, ensuring product quality, patient safety, and operational efficiency.

Job Responsibilities Production Oversight:

Directly supervise and oversee 503(b) compounding operations, including aseptic processing and terminal sterilization activities. Ensure adherence to batch production records (BPRs) and standard operating procedures (SOPs). Monitor production activities to maintain compliance with c

GMP, FDA 503

(b) outsourcing facility regulations, and State of Florida pharmacy board requirements.

Regulatory Compliance:

Ensure all operations comply with applicable state and federal pharmacy laws and FDA regulations. Maintain the pharmacy license and ensure all processes meet Florida Board of Pharmacy standards. Conduct regular documentation reviews and approve production batch records to ensure completeness and accuracy.

Quality Assurance:

Collaborate with the Quality Assurance (QA) team to ensure that compounded and terminally sterilized pharmaceuticals meet quality and safety standards. Participate in quality investigations, deviations, corrective and preventive actions (CAPAs), and audits. Support validation activities, including aseptic process simulations (media fills) and sterilization process validations.

Team Leadership and Training:

Provide leadership, training, and technical support to compounding technicians and other personnel. Ensure all staff are trained and competent to perform duties in compliance with GMP and regulatory requirements. Foster a culture of continuous improvement, safety, and quality.

Operational Responsibilities:

Monitor and ensure accurate labeling, documentation, and traceability of compounded products. Collaborate with supply chain and production teams to manage inventory of raw materials, consumables, and sterile components. Assist with process improvements to optimize production efficiency while maintaining compliance and quality standards.

Job Requirements Education:

Education:

Bachelor's or Doctor of Pharmacy (PharmD) degree from an accredited institution.

Licensure:

Must hold an active Registered Pharmacist license in the State of Florida. Preferred active Registered Pharmacist license in multistate.

Experience:

Minimum of 3 years of experience in pharmaceutical compounding or sterile manufacturing. Experience with 503(b) outsourcing facilities and aseptic/terminal sterilization processes preferred.

Knowledge, Skills and Abilities Knowledge:

Strong understanding of c

GMP, 503

(b) outsourcing regulations, FDA guidelines, aseptic/sterile compounding principles, USP 797 & USP 800. Familiarity with environmental monitoring, gowning, and aseptic techniques in controlled manufacturing environments. Preferred BCSCP (Board Certified Sterile Compounding Pharmacist) by BPS (Board of Pharmacy Specialties)

Skills:

Excellent organizational, communication, and leadership skills. Proficiency in reviewing and maintaining documentation, including batch records and SOPs. Strong problem-solving skills and attention to detail.

Work Environment:

Work is performed in a cleanroom environment that requires appropriate aseptic gowning and adherence to strict aseptic protocols. May require extended periods of standing, walking, or lifting in a production setting. Regular interaction with production equipment and materials in sterile and controlled environments.