Position Summary: The Compounder I adds chemicals, dyes, and other ingredients into the compounding kettles according to specifications and procedures listed in approved compounding mixing instructions. The Compounder I follows all Swiss-American CDMO SOPs, FDA, GMP, ISO, and OSHA guidelines. The Compounder I over sees all of the equipment that is used during the compounding of the batch.
Essential Duties and 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.”
- Weigh the tote(s) or drum(s) that the finished product is off loaded into.
- Follows Good Manufacturing Practice and Good Documentation Practices during all phase of compounding operations.
- Observes quality of product and notifying compounding management of any anomalies or concerns.
- Observes and compare 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 50lbs with assistance.
- Observes operation of equipment and notifying 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.
- Adjust controls to regulate temperature, pressure, feed or flow of liquids and times of prescribed reactions, according to knowledge of equipment and processes.
- Record operational data, such as temperatures, pressures, ingredients used, processing times, or test results.
- Must be able to submit samples
- Observes safety precautions to prevent incidents and injuries.
- 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 send them to laboratories for testing.
- Records samples that need to be sent out for testing in the “Bulk Product Samples Log.”
- Completes all documents with accuracy 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 Tier I formulas
- Ability/Willingness to learn Compounder II duties and responsibilities
- Other duties may be assigned.