Sterile Compounding Technician Supervisor

Sterile Compounding Technician Supervisor

AVEVA DRUG DELIVERY SYSTEMS INC - 3.7

Tamarac, FL Job Details Full-time 1 day ago Benefits Paid holidays Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Qualifications IV compounding Pharmacy Technician License PTCB Certification High school diploma or GED Team management Pharmaceutical plant experience Cleanroom Sterile laboratory techniques Delegation Compounding medications

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 Sterile Compounding Technician Supervisor oversees day-to-day operations within the sterile compounding suite of a federally registered 503B outsourcing facility. This role is responsible for supervising compounding technicians, ensuring compliance with current Good Manufacturing Practice (cGMP) standards, USP 797, USP 800 and supporting the Pharmacist in Charge (PIC) in maintaining quality systems, regulatory readiness, and production throughput. This is a working supervisory role requiring hands-on participation in sterile preparation activities alongside administrative and leadership responsibilities.

Key Responsibilities:

Supervision & Leadership Directly supervise sterile compounding technicians across all production shifts; assign tasks, manage scheduling, and monitor performance Conduct onboarding, competency assessments, and ongoing training for new and existing technicians in aseptic technique and cGMP practices Identify performance issues and work with the PIC to implement corrective actions or performance improvement plans Lead shift briefings, team huddles, and production planning meetings Serve as first point of escalation for technician questions, equipment issues, and operational disruptions Sterile Compounding Operations Actively participate in and oversee aseptic preparation of sterile drug products including large/small volume parenteral, ophthalmic, and other sterile dosage forms Ensure proper execution of master formula records (MFRs), batch production records (BPRs), and labeling per facility SOPs Monitor cleanroom environmental conditions (pressure differentials, temperature, humidity) and ensure ISO classification integrity Verify personnel gowning compliance and aseptic technique adherence for all cleanroom personnel Oversee compounding equipment operation, troubleshooting, and coordination of calibration/preventive maintenance schedules Quality & Regulatory Compliance Ensure all compounding activities comply with c

GMP, FDA 503B

outsourcing facility requirements, and applicable Florida Board of Pharmacy regulations Assist the PIC and Quality team with internal audits, deviation investigations, CAPA initiation, and out-of-specification (OOS) event documentation Review and approve batch records and in-process checks before product release to QC/QA Oversee environmental monitoring (EM) sampling schedules and work with QA to trend EM results Support preparation and readiness activities for FDA inspections, state board inspections, and third-party audits Maintain documentation integrity and ensure real-time, accurate completion of all required records Inventory & Supply Chain Monitor API, excipient, and component inventory levels; coordinate with procurement to prevent supply shortages Ensure proper receipt, quarantine, and release of incoming materials in coordination with QA Manage controlled substance logs and ensure DEA compliance for any scheduled compounds produced Continuous Improvement Identify workflow inefficiencies and propose process improvements to increase throughput and reduce error risk Participate in SOP review cycles and contribute to updating compounding procedures Stay current on evolving 503B regulations, USP chapter revisions, and FDA guidance documents

Education:

High school diploma or GED required; Associate or Bachelor degree in a science-related field preferred Active Florida Pharmacy Technician license in good standing (required) PTCB Certified Pharmacy Technician (CPhT) required; CSPT (Certified Sterile Products Technician) credential strongly preferred

Knowledge, Skills and Abilities:

Experience with automated compounding devices (e.g., Exacta-Mix, Baxa Repeater Pump, gravimetric systems) Familiarity with environmental monitoring programs, viable/non-viable particle sampling, and EM trend analysis Working knowledge of LIMS, pharmacy compounding software (e.g., BeyondTech, PharmacyOS, or similar) Experience supporting

FDA 503B

inspections or state pharmacy board inspections Exposure to Lean, Six Sigma, or other continuous improvement methodologies

Experience:

Minimum 5 years of sterile compounding experience, with at least 2 years in a 503B outsourcing facility or hospital IV compounding environment Minimum 1-2 years of supervisory or lead technician experience Demonstrated proficiency in aseptic technique, ISO 5/7/8 cleanroom operations, and USP and USP compliance Strong working knowledge of cGMP documentation practices and batch record completion

Physical & Environmental Requirements:

Must be able to stand for extended periods (6-10 hours per shift) in a controlled cleanroom environment Must be able to wear full gowning (coverall, goggles, gloves, face mask, shoe covers) for sustained periods Ability to lift up to 30 lbs; perform repetitive hand and wrist motions Must be free of conditions that would preclude safe working with hazardous drug preparations (where applicable) May be required to work evenings, weekends, or rotating shifts depending on production demands

Benefits :

Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan Medical/Dental/Vision Insurance Paid Time Off 401k with employer match Paid Holidays and Floating Holiday Equal Opportunity Employer