Sterile Compounding Technician Supervisor

AVEVA DRUG DELIVERY SYSTEMS INC•Tamarac, FL

1d•Onsite

About The Position

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. 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.

Requirements

High school diploma or GED required
Active Florida Pharmacy Technician license in good standing (required)
PTCB Certified Pharmacy Technician (CPhT) required
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 <797> and USP <800> compliance
Strong working knowledge of cGMP documentation practices and batch record completion

Nice To Haves

Associate or Bachelor degree in a science-related field preferred
CSPT (Certified Sterile Products Technician) credential strongly preferred
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

Responsibilities

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
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
Ensure all compounding activities comply with cGMP, 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
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
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