Compounder II

Swiss American CDMO•Carrollton, TX

2h•Onsite

About The Position

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

Requirements

High School Diploma or equivalent
Minimum 3-4 years of experience in a manufacturing environment
2-3 years of experience as a Compounder (preferred)
Strong oral and written English communication skills
Basic oral proficiency in Spanish (preferred)
Ability to read and understand simple instructions and technical documents
Proficient in basic arithmetic (addition, subtraction, multiplication, division)
Ability to perform calculations using units of measure (metric and imperial)
Ability to follow detailed instructions and work independently
Strong attention to detail and ability to identify and resolve minor production issues
Basic computer skills (e.g., email, data entry)
Valid forklift operator certification
Must be able to operate a forklift safely and efficiently

Nice To Haves

2-3 years of experience as a Compounder (preferred)
Basic oral proficiency in Spanish (preferred)

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 read 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 compliance during all phases 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.
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.
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 send them to laboratories for testing.
Records samples that need to be sent out for testing in the “Bulk Product Samples Log.”
Flush or clean equipment, using steam hoses or mechanical reamers.
Drain equipment and pump 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 dual-kettle formulas
Have a complete understanding of all Compounder I duties/responsibilities
Ability/Willingness to learn Compounder III duties/responsibilities, including cross-training on tri-kettle formulas
Must be able to submit samples
Must be able to take on duties and responsibilities of a Compounder III when absent
Other duties may be assigned.