Compounder III

About the role

The Compounder III adds chemicals, dyes, and other ingredients into the compounding kettles according to specifications and procedures listed in approved compounding mixing instructions. The Compounder III follows all Swiss American CDMO SOPs, FDA, GMP, ISO, and OSHA guidelines. The Compounder III oversees all of the equipment that is used during the compounding of the batch.

Responsibilities

• Reviews the Pick List, Batch Record Audit Log, and verifies that all materials are present and weighed out accurately before starting the compounding of any batches.
• Thoroughly reads the mixing instructions before starting the batch.
• Verifies that all equipment that is to be used is cleaned and within the “Use by Date” before the start of any compounding.
• Records all equipment used in the “Equipment Use Log.”
• Weighs the tote(s) or drum(s) that the finished product is off loaded into.
• Follows Good Manufacturing Practice compliance during all phases of compounding operations.
• Observes quality of product and notifies compounding management of any anomalies or concerns.
• Observes and compares colors and consistencies of products to instrument readings and to laboratory and standard test results.
• Assures products meet documented specifications as required.
• Able to lift a maximum of 50 lbs.
• Observes operation of equipment and notifies compounding management and/or maintenance department of any anomalies and/or concerns.
• Inspects equipment for any defects or malfunctions and shuts equipment down, if necessary.
• Adjusts controls to regulate temperature, pressure, feed or flow of liquids and times of prescribed reactions, according to knowledge of equipment and processes.
• Records operational data, such as temperatures, pressures, ingredients used, processing times, or test results.
• Observes safety precautions to prevent fires or explosions.
• Obtains samples of products at specified stages so that analyses can be performed.
• Tests product samples for specific gravity, chemical characteristics, pH levels, concentrations, or viscosities or sends them to laboratories for testing.
• Records samples that need to be sent out for testing in the “Bulk Product Samples Log.”
• Flushes or cleans equipment, using steam hoses or mechanical reamers.
• Drains equipment and pumps water or other solutions through to flush and clean tanks or equipment.
• Completes all documents properly and calculates all information needed on batch records.
• Performs closing duties if required.
• Assists in the weighing of chemicals, if needed.
• Must be able to compound tri‑kettle formulas.
• Has a complete understanding of all Compounder II duties/responsibilities.
• Ability/willingness to learn Compounder Team Lead duties/responsibilities, including cross‑training on tri‑kettle formulas for a Comp