Compounder III

Swiss American CDMO•Carrollton, TX

6d•Onsite

About The Position

The Compounder III adds chemicals, dyes, and other ingredients to compounding kettles according to approved mixing instructions and procedures. The role follows Swiss American CDMO SOPs and applicable FDA, GMP, ISO, and OSHA guidelines, and oversees equipment used during batch compounding. The Compounder III verifies materials and equipment before production, monitors product and equipment quality, adjusts process controls, collects and tests samples, cleans equipment, and completes batch documentation. The position also requires the ability to compound tri-kettle formulas, perform Compounder II duties, and take on Compounder Team Lead responsibilities when needed.

Requirements

High school diploma or equivalent.
At least one year of manufacturing experience.
One to two years of compounding experience.
Excellent written and verbal communication skills in English.
Ability to communicate effectively with peers and management.
Basic arithmetic skills using a calculator.
Ability to perform calculations using American and International units of weight and volume.
Ability to exercise sound judgment, make informed decisions, and escalate issues to management when appropriate.
Basic computer skills.
Ability to lift and/or move up to 50 pounds, with assistance if required.
Ability to compound tri-kettle formulas and perform Compounder II duties and responsibilities.

Responsibilities

Review the Pick List and Batch Record Audit Log, and verify that all materials are present and accurately weighed before compounding.
Read mixing instructions thoroughly before starting a batch.
Verify that equipment is clean and within its “Use by Date,” and record equipment used in the Equipment Use Log.
Weigh the totes or drums used to receive finished product.
Follow Good Manufacturing Practice requirements throughout compounding operations.
Monitor product quality, compare product colors and consistencies with instrument readings and laboratory or standard test results, and notify management of anomalies or concerns.
Ensure products meet documented specifications.
Observe equipment operation, report anomalies or concerns to management or maintenance, inspect for defects or malfunctions, and shut equipment down when necessary.
Adjust controls for temperature, pressure, feed or liquid flow, and reaction times according to equipment and process requirements.
Record operational data, including temperatures, pressures, ingredients, processing times, and test results.
Follow safety precautions to prevent fires or explosions.
Collect product samples at specified stages, test samples for specified characteristics or send them to laboratories, and record samples sent for testing in the Bulk Product Samples Log.
Flush, clean, and drain equipment, including pumping water or other solutions through tanks or equipment.
Complete documents properly and calculate information required on batch records.
Perform closing duties when required and assist with weighing chemicals when needed.
Compound tri-kettle formulas and perform all Compounder II duties and responsibilities.
Learn Compounder Team Lead duties and responsibilities, including cross-training on tri-kettle formulas for a Compounder II.
Submit samples and take on Compounder Team Lead duties and responsibilities when the team lead is absent.
Perform other duties as assigned.