Swiss American CDMO, LLC
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 include the following. Other duties may be assigned.
- 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 compliance 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.
- 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 3 kettle formulas
- Wound Cleansers
- Ability/Willingness to learn Compounder II duties and responsibilities
- Must be able to take on the duties and responsibilities of a Compounder II when absent
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
High school diploma education; at least one year of compounding experience and 0 – 2 years of Compounder experience.
Strong oral and written English skills basic oral Spanish and the ability to read a limited number of two- and three-syllable words and to recognize similarities and differences between words and between series of numbers. Ability to print and speak simple sentences.
Ability to add, subtract, multiply, and divide using a calculator. Ability to perform these operations using units of American and International weight measurement and volume.
Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.
Some Computer skills required.
Certificates and Licenses:
Forklift certified, while also being able to operate the forklift in a safe manner.
No supervisor responsibilities.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must frequently lift and/or move up to 50 pounds. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel and reach with hands and arms. The employee is frequently required to stand. The employee is occasionally required to walk.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.