Hardshell Operator

Under the direction of supervision (i.e. supervisor and/or team leader), the machine processor is responsible for changeovers, operating, packing, loading and preparing assigned equipment and machinery for use to meet production schedules.  

PRODUCTION

• 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.

QUALITY

• 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.

HEALTH and SAFETY

• 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.

EXPERIENCE

Minimum

• 3+ months machine operation experience in a manufacturing environment.

Preferred

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

EDUCATION

• High school diploma or equivalent

QUALIFICATIONS

COMPUTER SKILLS – Capacity to perform basic computer transactions.

LANGUAGE SKILLS - Ability to read and comprehend simple instructions, short correspondence, and memos in English. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to other employees of the organization.

MATHEMATICAL SKILLS - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

REASONING ABILITY - Ability to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.

PREFERRED ATTRIBUTES

• 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.

PHYSICAL DEMANDS

• 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.

While performing the duties of this job, the employee is regularly required to talk or hear and sit. The employee is occasionally required to reach with hands and arms. Specific vision abilities required by this job include close vision and attention to detail.

WORK ENIVORNMENT 

• 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.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job.  This job description reflects management’s assignment of essential job functions, which are not intended to be an exhaustive list of all responsibilities, duties and skills required.