Machine Operator: Blending D (6p-6a)

• Properly changeover, disassemble, clean, reassemble and operate all production related equipment in the assigned department in a safe and efficient manner.
• Operation of necessary machinery related to the job classification including documentation of the processing steps in the batch record and/or other necessary paperwork (i.e. initial setup, raw material usage, quality/weight checks and finished product quantity).
• Setup, operating, adjusting programmable logic control (PLC) equipment for each batch formulation (minimum 10 or more daily).
• Responsible for breaking-down, cleaning, tooling, setting up and preparing solution for (if required) equipment Pull, deliver and stage all materials needed; Complete stock and raw/in-process/finished material transfers.
• Troubleshooting and monitoring equipment: hand tools, viscosity meters, pneumatic equipment, pressers, melters, coaters, blenders, technophars, turret lifts, dust removers, part washers, hoppers, mills and solution tanks.
• Utilize Mettler moisture analyzers to perform moisture checks on core products.
• Must adhere to work instructions to ensure a consistent material is generated per customer specifications are achieved in an safe, effective and efficient manner.
• Utilize company ERP system (AS400) for inventory transactions, scanning, label creation, verifying additions to batch records and data entry.
• Utilize Microsoft Office Suite (Word, Excel and Outlook) to log production outputs, create product start-up documents to record relative standard deviations (RSDs), friability, disintegration, reliability/quality testing).
• May use (but not limited to) power equipment such as a forklift, hand tools, and other devices operated in a warehouse environment (i.e. electric jacks, sit down, stand ups, and cherry picker forklifts for applicable area(s).
• Monitor and adjust machine parameters in specification to maintain finish product quality and ensure proper machine operation.
• Ensure that codes/lots and finished products are not mixed.
• Removal and reconciliation of excess and unused materials.
• Perform calibrations as necessary to keep all parameters in specification.
• Perform routine preventative maintenance: Routine clean-up during operation, quick clean between lots, and full clean when required.
• Other duties as assigned, overtime as required.

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  Adherence to the Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs) in effect assuring the quality and quantity of product produced is required.
• Maintain clean work environment at all times, including and not limited to hygiene practice.
• Follow batch record instructions and maintain accurate and legible production records.
• Responsible for performing rework tasks throughout the codes/lots.
• Ensure proper labeling of finished product while completing all necessary paperwork / documentation as required (i.e. batch records).
• Ensure proper recording and usage of batch records per established processes.
• Accumulate all rejects and place into the appropriate containers for proper disposal or rework process.
• Must keep work area clean and free of stray / foreign product.

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  Know and understand the cGMP and other regulatory compliance.
• Ensure job specific safety procedures are established and followed.
• Maintain awareness and enforcement of health and safety practices and activities.
• Be involved in the development, implementation, and updating of health and safety plans and procedures.
• Actively participate in health and safety training programs and demonstrate competency based on training received.
• Actively participating in health and safety activities.
• Ensuring compliance with regulatory requirements.
• Ensuring adequate resources are provided.
• Providing suggestions for improvement to the health and safety program.

Minimum

• 3 months machine operation experience in a manufacturing environment.

• 3 months experience in stated position within Nutra Manufacturing operations.
• 1 year experience machine operations or similar in a GMP/FDA regulated manufacturing environment.

• High school diploma or equivalent

• Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
• Dependability — Job requires being reliable, punctual, responsible, and dependable, and fulfilling obligations.
• Integrity — Job requires being honest and ethical.
• Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace.
• Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
• Self Control — Job requires maintaining composure, keeping emotions in check, controlling anger, and avoiding aggressive behavior, even in very difficult situations.
• Independence — Job requires developing one's own ways of doing things, guiding oneself with little or no supervision, and depending on oneself to get things done.
• Initiative — Job requires a willingness to take on responsibilities and challenges.
• Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations.
• Concern for Others — Job requires being sensitive to others' needs and feelings and being understanding and helpful on the job.

• Climb or balance on step stools or ladders.
• Operate floor jack and / or industrial power lifts as required.
• Occasionally required to push/pull up to 1000 pounds carry/lift up to 50 pounds and regularly lift up to 25 pounds.

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  Moderate to high levels of noise – requires awareness to surrounding due to equipment in use.
• Working environment may be dusty, oily and/or slippery.
• Slip-resistant or steel toe safety shoes are required.
• Personal protective equipment (PPE) as required.
• Dust mask, gloves and goggles may be required in designated areas.