COMPOUNDER II

**PRIMARY PURPOSE:** The primary function of this role is to assist a Compounder II or higher in executing blending and compounding operations in a regulated OTC pharmaceutical environment. Responsibilities include equipment staging, cleaning, material handling, and documentation — all performed in strict accordance with **cGMP**, **FDA regulations**, and **internal SOPs** to ensure consistent product quality and regulatory compliance. **MAJOR DUTIES AND RESPONSIBILITIES:** - **Strictly adhere** to all current Good Manufacturing Practices (cGMP), FDA 21 CFR Part 211 requirements, company SOPs, and safety protocols to ensure a compliant, safe, and controlled production environment. - **Perform and document** all cleaning, sanitization, and preparation activities in accordance with **approved Batch Records**, **SOPs**, and **GDP (Good Documentation Practices)**. - Immediately report any discrepancies, unclear instructions, or deviations to Compounding Supervision or Engineering for resolution. - Maintain a **clean, organized, and audit-ready work area** at all times to ensure contamination control and inspection readiness. - Participate in **5S programs and continuous improvement initiatives** to support production efficiency, equipment readiness, and workflow standardization. - Provide day-to-day operational support to the **Compounding and Production teams**, ensuring timely execution of production goals. - Use **NetSuite and RFSmart**to: - Perform inventory transactions including transfers, consumptions, and completions. - Verify expiration and retest dates of raw materials before use. - Generate and apply appropriate identification labels for traceability and batch compliance. - Assist with **setup and staging** of equipment such as scales, homogenizers, blending tanks, pumps, and hoses according to batch record instructions. - Record all processing parameters (e.g., weights, volumes, temperatures) in batch documentation with precision and in compliance with GDP. - Perform **material charging** to blending vessels per batch record instructions, ensuring prevention of cross-contamination or material mix-ups. - Execute **line clearance and cleaning** procedures between batches (lot-to-lot or full clean), including breakdown and cleaning of all required equipment as per validated procedures. - Safely operate manual and electric pallet jacks to transport raw materials, equipment, stainless steel totes, and production containers within GMP areas. - Demonstrate and promote a **Quality First Mindset**: - Understand critical quality attributes and process parameters associated with compounding operations. - Identify and immediately escalate any quality issues to Supervision and Quality Assurance. Cease operations when product quality is at risk. - Support other production or compounding-related functions as needed, including: - Assisting on packaging lines during bottlenecks or downtime. - Cleaning and sanitizing auxiliary equipment, containers, and processing tools. - Operating floor scrubbers or other cleaning equipment to maintain facility hygiene. **QUALIFICATION:** **Required:** - Fluent in reading, writing, and verbal communication in English. - Demonstrated commitment to personal hygiene and cleanliness, in compliance with **GMP and FDA OTC regulations**. - Strong basic math skills, including weight and volume conversions, percentages, and accurate measurements. - Ability to follow detailed written procedures (Batch Records, SOPs) and verbal instructions without deviation. - Familiarity with calibrated measurement equipment (scales, beakers, graduated cylinders, etc.). - Understanding of and adherence to safety protocols, including handling of cleaning chemicals and operation of production equipment. - Exceptional attention to detail with a proactive approach to identifying discrepancies or non-conformances. - Physically capable of lifting 50–75 lbs and working in environments with exposure to hot water, steam, and chemical…