Role Summary
Operator II (Tues-Thurs 6:00am-6:30pm) will perform operations related to the manufacturing and/or packaging of pharmaceutical products, including equipment set-up, operation, clean-up and maintenance, in compliance with regulatory cGMP requirements and company policies and procedures.
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 WI's.
- 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
- Required: High School Diploma or equivalent.
- 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.
Additional Requirements
- Constant: Standing for extended periods of time at the work station or equipment.
- Frequent: Stooping, kneeling and/or crouching; twisting/reaching—turning at the waist and extending hands and/or arms in any direction.
- Occasional: Sitting for extended periods of time at the work station or mobile equipment; climbing; pushing and/or pulling; repetitive motions; lifting from 25 lbs up to 50 lbs, and more than 50 lbs with assistance.
- Visual Acuity: Performing activities such as computer work, data analysis, extensive reading, visual inspection involving small defects or parts, and operation of machines requiring close visual focus.