Operator I

Role Summary

This position is responsible for manufacturing and/or packaging pharmaceutical products, including equipment set-up, operation, clean-up, and maintenance, in compliance with cGMP requirements and company policies. The role involves learning the manufacturing/packaging process by following approved batch records, work instructions, and SOPs.

Responsibilities

• Learn the manufacturing and/or packaging process by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
• Set up, changeover, programming and operation of various equipment manufacturing and/or packaging equipment.
• Clean facilities, equipment and utensils as required following SOPs and WIs.
• Complete documentation as required in the manufacturing and/or packaging of product.
• Complete all training requirements and maintain 100% compliance with all assignments.
• Maintain work areas and perform job functions in a safe and efficient manner in accordance with company policies and procedures, cGMPs, SOPs and Batch Record instructions.
• Perform additional related duties as assigned.

Qualifications

• Any equivalent combination of education, training and/or experience that fulfills the requirements will be considered.
• Preferred: previous pharmaceutical manufacturing or packaging experience.

Skills

• Ability to receive instruction and follow directions.
• Ability to interact positively with co-workers and management.
• Ability to communicate effectively with written and oral communication skills.
• Ability to follow company policies and procedures.
• Ability to follow cGMP and other regulatory requirements.
• Ability to maintain 100% compliance in all SOP, cGMP, EHS and other training curriculum as assigned.
• Ability to operate and troubleshoot manufacturing/packaging equipment.
• Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
• Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
• Normally receives general instruction on routine work and detailed instruction on new assignments.
• May be asked to recommend methods and procedures for problem resolution.

Education

• High School Diploma or equivalent.

Additional Requirements

• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Stooping, kneeling and/or crouching – bending body, spine and/or legs.
• Twisting/reaching – turning at waist and extending hands and/or arms in any direction.
• Sitting for extended periods of time at work station or mobile equipment.
• Climbing – use of feet, legs, hands and/or arms to ascend or descend.
• Pushing and/or pulling – using upper extremities to exert force.
• Repetitive motions - frequent motions of the wrists, hands and/or fingers.
• Lifting – raising from lower to upper and/or moving objects horizontally – from 25 lbs, up to 50 lbs and more than 50 lbs (with assistance).
• Visual acuity for computer work, data analysis, extensive reading, visual inspection of small defects, small parts and/or operation of machines, and use of measurement devices.