Description:
The Transdermal Operator I supports transdermal manufacturing and packaging operations in a cGMP-regulated environment. This role includes operating equipment under supervision, assisting in basic mixing, coating, and converting activities, performing in-process inspections, completing documentation, and maintaining a clean and safe work area.
Day Shift - 12-hour rotating schedule (6:00 AM – 6:30 PM)
Essential Functions:
- Assist with equipment set-up, IQ/OQ/PQ, ANDA, and commercial batch activities per cGMP and SOP requirements.
- Set up and operate packaging, cartoning, and selected transdermal manufacturing equipment under supervision.
- Assist in mixing, coating, and converting operations by preparing materials, loading equipment, monitoring runs, and performing basic adjustments per SOP.
- Perform packaging room clearance, material counts, and reconciliation activities.
- Conduct in-process checks and visual inspections to ensure product quality.
- Document batch activities, in-process checks, and logbook entries accurately and in a timely manner.
- Perform room and equipment cleaning after each batch.
- Maintain a clean, organized, and safe work environment.
- Report deviations, equipment issues, or safety concerns to the Supervisor.
- Follow all cGMP, SOP, OSHA, and safety requirements.
- Perform other duties as assigned.