Compounder - 1st and 2nd Shifts

Scope:

The Compounder performs all operations related to the compounding of bulk products in accordance with all applicable standard operating procedures (SOP) and work instructions (WI). 

Primary Responsibilities/Accountabilities:

• Stages, verifies, delivers and compounds in the appropriate batching tank all raw materials required for bulk product manufacturing.
• Performs all SAP transactions related to the movement of raw materials and bulk product, and ensures accurate inventory balances.
• Performs visual quality checks of raw materials, identifies discrepancies and/or adverse chemical reactions and initiates resolution.
• Performs calibration and maintenance checks on all compounding equipment and reports any out-of-tolerance variations to management.
• Adjusts mixer speeds to accommodate differences in processing equipment and raw material reactions.
• Obtains in-process batching samples and delivers to the quality control lab for testing.
• Cleans and sanitizes assigned tanks, piping, fittings, pumps and other related equipment in accordance with SOP and WI.
• Completes all documentation according to standard operating procedures (SOPs) and work instructions (WI). 
• Performs product rework as required.
• Operates all processing and powered industrial equipment according to operational procedures, safety requirements and GMP regulations.
• Performs all work in a manner that is consistent with the company’s quality system and FDA good manufacturing practices, includes maintaining a clean and orderly area at all times.
• Follows, promotes and enforces KDC’s safety and environmental policies, practices and procedures.
• Performs other duties as assigned.

Education & Experience:

• High school diploma/GED equivalent with proficiency in math and reading comprehension.
• Compounding/processing, pre-weigh or sanitization experience preferred.
• SAP experience strongly preferred.

Knowledge, Skills, & Abilities:

• Ability to promote and participate in a team-oriented and collaborative environment.
• Ability to adapt to rotating assignments with a positive attitude and results.
• Strong problem solving, analytical methods and technical skills.
• Good understanding of FDA Good Manufacturing Practices Regulations (GMP’s) and OSHA safety requirements.
• Self-starter with strong work ethic and positive attitude.
• Strong communication (both written and oral), interpersonal, team building and organizational skills.
• Must be able to understand and complete procedure documents in accordance with SOPs and WIs.
• Ability to perform multiple tasks simultaneously and manage time efficiently and effectively.
• Strong computer skills (Microsoft Office)

• Ability to use measuring and testing devices.

Minimum Requirements:

• Must be 18 years or older.
• Able to work overtime & weekends as required.
• Wear hairnet, safety glasses, long pants, steel toe shoes/boots and any other uniform standards.

• Read, comprehend and follow written and verbal instructions, including SOPs.

• Sit, bend, stoop, climb, and stand for long periods of time in one place.
• Lift items up to 80 lbs. and move drum containers weighing up to 600lbs using the appropriate powered industrial equipment.

• Exposure to a variety of cleaners and sanitizers, hot water and chemicals.
• Ability to work in a wet environment.

This above Job Description is not intended to be an all-encompassing list of responsibilities, skills, efforts, or working conditions associated with this position. It is intended to be a guideline reflecting the principle activities.