Operator II (Tues-Thurs 6am-6:15pm)

Role Summary

Operator II (Tues-Thurs 6am-6:15pm) is responsible for performing operations related to the manufacturing and/or packaging of pharmaceutical products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures.

Responsibilities

• All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.
• Responsible for set up, changeover, programming and operation of various equipment manufacturing and/or packaging equipment.
• Responsible for cleaning of facilities, equipment and utensils as required following SOPs and WIs.
• Responsible for completing documentation as required in the manufacturing and/or packaging of product.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, cGMPs, SOPs and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Qualifications

• Required: High School Diploma or equivalent; any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
• Preferred: Previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries; minimum 2 years’ 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, set up 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

• Requires 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.
• Twisting and reaching – turning at waist and extending hands/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 (25 lbs, up to 50 lbs; more than 50 lbs with assistance).
• Visual acuity for activities such as computer work, data analysis, extensive reading, visual inspection involving small defects, small parts and/or operation of machines and measurement devices.