Compounder II

Swiss American CDMO, LLC.; Town of Texas (WI); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Compounder II for their Carrollton, TX location. In this full-time role, you will be responsible for compounding materials in accordance with specific procedures and guidelines, while ensuring quality and safety standards are upheld. The ideal candidate will possess strong communication skills, a background in manufacturing, and the ability to lift up to 50lbs. If you're dedicated and detail-oriented, we encourage you to apply.

Qualifications

• 3-4 years of experience in a manufacturing environment.
• 2-3 years of experience as a Compounder preferred.
• Valid forklift operator certification required.

Responsibilities

• Add chemicals and ingredients into kettles per specifications.
• Ensure compliance with GMP, FDA, ISO standards.
• Verify equipment is clean and operational.

Skills

Attention to detail

English communication

Basic arithmetic

Forklift operation

Education

High School Diploma or equivalent

Job description

Job Details

Job Location: Corporate - CARROLLTON, TX

Position Type: Full Time

Salary Range: Undisclosed

Job Shift: Evening

Description

Position Summary: 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.

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 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.

Qualifications

Essential Skills and Qualifications:

• 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

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

Physical Demands:

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 accommodation 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.