Role 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.
Responsibilities
- 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.
Qualifications
- 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.
- Requires High School Diploma or equivalent.
- Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
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.
Education
- Requires High School Diploma or equivalent.
- Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries.
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, inspection and measurement.