Compounder I

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. 

Qualifications

Essential Skills and Qualifications:

• 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 effectively communicate with peers and management.
• Proficiency in basic arithmetic (addition, subtraction, multiplication, division) using a calculator.
• Ability to perform calculations using both American and International units of weight and volume.
• Ability to apply sound judgment and make informed decisions.
• Ability to escalate issues to management when appropriate.
• Basic computer skills are required.

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 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 with assistance, if required. 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.