Operator I

Position Summary

 

• This position 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.
  
   

Essential Duties & 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 SOP’s and WI’s.
• 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, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.
  
   

Position Requirements

 

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

Education/Certification/Experience

 

• Requires High School Diploma or equivalent.
• Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
  
   

Skills/Knowledge/Abilities

 

• 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.
  
   

Problem Solving

 

• 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.
  
   

Constant

Physical requirements:

 

• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
  
   

Frequent:

 

• 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.
  
   

Occasional:

 

• 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

 

• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes