Posted 1mo ago

Compounder

@ Swiss American CDMO
CARROLLTON, Texas, United States
OnsiteFull Time
Responsibilities:Review materials, Read instructions, Verify equipment
Requirements Summary:High school diploma; 1-3 years manufacturing; 1-2 years compounding; English communication; basic math; ability to lift up to 50 lbs; good teamwork.
Technical Tools Mentioned:Calculator, Basic computer skills
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Job Description

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.