Production Operator - Days

Summary

The Production Operator reports to the Shift Supervisor and is responsible for learning and performing various pharmaceutical manufacturing techniques including any or all of: dispensing, blending and granulation, compression, encapsulation, and coating.

Responsibilities

• Cleaning of product rooms and equipment such as mills, mixers, ovens, granulators etc.
• Operation of granulation equipment
• Operate all Coating equipment, dust collector, air handling unit and delivery apparatus.
• Check and document weight of all powder blends when received from Blending Department
• Compress/Encapsulate product as specified in the batch Manufacturing Records.
• Document process as specified in BMR
• Operate all Encapsulation equipment i.e., IMA Matic 90, IMatic 150, Adapta encapsulators, Precisa 12, 120 weight sorters, scales and metals detectors.
• Clean all equipment in the Encapsulation and Tablet Compression department
• Operate all tablet compression equipment i.e. Kilian S520, Syntheses 500, tablet presses, drum lifters, deduster, metal detectors, scales, micrometers, hardness testers, printers, and inspection machines
• Will assure the Department and work areas are kept clean and orderly.
• Clean equipment as specified by SOPs and Department Supervisor.
• Will constantly observe and practice all cGMP policies and procedures in all work performed.
• Observe and adhere to Department Standard Operating Procedures (SOPs) and Safety Polices in all work performed.
• Adhere to work schedule
• Must participate and successfully complete all training as required by the company.
• Perform other duties as assigned.

Experience, Education, and Skills Required

• High School diploma or equivalent GED.
• Experience in a GMP environment, preferably in Oral Solid Dose manufacturing or working in a similar capacity
• Good computer skills as well as communications, both oral and written
• Ability to add, subtract, multiply, and divides in all units of measure, using whole numbers, common fractions, and decimals
• Ability to apply commonsense understanding to carry out detailed written or oral instructions furnished in written, oral or diagram form.
• Experience with use of a computer for completing training and interfacing with mechanical systems and/or control systems.
• Must be able to pass pre-employment criminal background and drug screenings, as well as a physical in order to wear proper personal protective equipment such as a respirator, and lift or move materials as needed

Physical Requirements

• The employee is required to: stand, walk, push, pull, twist, reach overhead, and bend to the floor
• The employee may be required to wear personal protective equipment (PPE) during certain phases of the operation; such as high noise areas from machinery, exposure to a variety of chemicals, or exposure to dust, mists, and fumes.
• occasionally move items or equipment
• occasionally required to climb ladders and/or steps to reach equipment
• Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
• Must have sense of smell to detect odors of unacceptable compounds and/or mixtures.
• Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.