Operator I

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 in primary and secondary packaging or manufacturing. Shift Schedule: Dayshift, Tuesday-Thursday, 6:00am-6:15pm with some mandatory overtime on Mondays or Fridays 6:00am-2:30pm.

Responsibilities

• Learn the manufacturing and/or packaging process by following approved batch records, work instructions, and standard operating procedures.
• Set up, changeover, programming and operation of various manufacturing and/or packaging equipment, including R&D operator work.
• Clean facilities, equipment and utensils as required per SOPs and WI.
• Complete documentation related to the manufacturing and/or packaging of product.
• Complete training requirements and maintain 100% compliance with assignments.
• Maintain work areas and perform job functions safely and efficiently in accordance with policies, cGMP, SOPs and Batch Record instructions.
• Perform additional related duties as assigned.
• Must be able to wear a PAPR during shift.
• Must be able to go up and down steps in production rooms frequently throughout the shift.

Qualifications

• Requires High School Diploma or equivalent.
• Prefer a minimum of 6 months prior 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 in written and oral form.
• 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 curricula as assigned.
• Ability to operate and troubleshoot manufacturing/packaging equipment.

Education

• Requires High School Diploma or equivalent.

Additional Requirements

• Ability to wear a PAPR during shift.
• Must be able to go up and down steps in production rooms frequently throughout the shift.