Compounding Supervisor Position Available In Volusia, Florida

Compounding Supervisor Job Description:

The Weigh-Up and Compounding Supervisor is responsible for overseeing and actively participating in the weighing, preparation, and compounding of raw materials for OTC and cosmetic products. This hands-on leadership role ensures all processes comply with

FDA 21 CFR

Parts 210 and 211, GMP (Good Manufacturing Practices), and company quality standards. The Supervisor will lead and train the weigh-up and compounding team while ensuring adherence to batch manufacturing records (BMRs), safety protocols, and production schedules.

Responsibilities:

Hands-On Weigh-Up and Compounding Activities Accurately weigh and measure raw materials following approved batch records and formulations. Perform compounding operations, ensuring proper mixing, blending, heating, and emulsification based on product specifications. Maintain control of pH, viscosity, and other key product parameters during compounding. Ensure proper handling and storage of raw materials, APIs, and chemicals per regulatory requirements. Follow First-In-First-Out (FIFO) for components and First-In-First-Expire (FIFE) for chemicals to ensure product integrity. Supervision & Team Leadership Lead and oversee the weigh-up and compounding team, ensuring accuracy, efficiency, and compliance with GMP. Train and mentor team members on proper weighing, compounding, documentation, and safety practices. Assign daily tasks and monitor progress to ensure production deadlines are met. Enforce adherence to company policies, safety regulations, and cleanliness standards. Provide feedback to employees, identify skill gaps, and recommend training opportunities. Compliance with FDA Regulations, GMP & SOPs Ensure all activities align with

FDA 21 CFR

210 and 211, OTC monograph requirements, and GMP standards. Follow and enforce Standard Operating Procedures (SOPs) for weigh-up and compounding. Maintain compliance with Good Documentation Practices (GDP), ensuring all records are accurate and complete. Support internal and external audits by providing necessary documentation and explanations. Equipment Operation & Maintenance Operate compounding equipment, including mixers, kettles, pumps, and filtration systems. Perform pre-operation checks to confirm equipment readiness and cleanliness. Ensure proper calibration and maintenance of scales, pH meters, and other lab instruments. Report any equipment malfunctions or deviations to management for corrective action. Batch Record Documentation & Quality Assurance Complete and verify all documentation, including BMRs, logs, and deviation reports, in real-time. Work closely with Quality Assurance (QA) to ensure compliance with product specifications and release requirements. Investigate and resolve any discrepancies in weigh-up or compounding processes. Support root cause analysis and corrective actions for non-conformances. Warehouse & Inventory Coordination Coordinate with warehouse personnel to ensure timely delivery of raw materials. Verify the integrity and identity of raw materials received, ensuring COA and SDS are available. Ensure that all weighed materials are labeled correctly and stored in the appropriate status (quarantine, approved, hold, or reject). Maintain accurate usage records and report material shortages or excesses to management. Workplace Safety & Cleanliness Enforce strict adherence to safety protocols, including PPE usage and chemical handling procedures. Conduct routine inspections of the weigh-up and compounding areas to ensure compliance with cleanliness and organization standards. Monitor and report any potential safety hazards or risks in the workplace. Ensure compounding rooms, weighing areas, and equipment are properly cleaned and sanitized according to SOPs.

Qualifications:

High school diploma or equivalent required; associate degree or technical certification in chemistry, pharmaceutical science, or manufacturing preferred. Minimum 3+ years of experience in compounding or weigh-up operations within an FDA-regulated OTC, pharmaceutical, or cosmetic manufacturing environment. Prior experience in a supervisory or team lead role preferred. Strong understanding of

FDA 21 CFR 210

& 211, GMP, and GDP requirements. Experience working with batch manufacturing records (BMRs), SOPs, and safety data sheets (SDS). Ability to operate and troubleshoot compounding equipment. Strong organizational, communication, and leadership skills. Ability to lift up to 50 lbs and work in a physically demanding environment.

Work Environment:

Operates in a manufacturing environment where adherence to safety, cleanliness, and GMP is critical. Frequent standing, lifting, and exposure to chemicals and raw materials. May require overtime or weekend work based on production P ay: $25/hr – $30/hr