Follow Master Batch Records for the packaging of controlled, oral solid dose (OSD) and other dosage forms when required.
Safely and in compliance with batch records and SOPs, set up, operate, and clean packaging equipment.
Perform in-process testing and inspections.
Clean and sanitize packaging equipment, parts, components, and rooms.
Complete accurate and timely documentation. Follow good documentation practices in accordance with GMP.
Process labeling and components correctly; transferring, counting, FIFO, returns, etc. during packaging processes.
Maintain regular and punctual attendance; work overtime as required.
Requirements:
High School Diploma or equivalent.
Three or more years pharmaceutical, packaging industry experience preferred; or an equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry.
General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
Preferred Skills:
Preferred experience in oral solid dose (OSD) pharmaceuticals Packaging with Serialization.
Clear, accurate, effective, and timely written and verbal communication.
Strong attention to detail and ability to write and record data legibly and accurately in accordance with cGMP regulations.
Ability to take ownership of work, doing what is needed without being asked and appropriate follow-through.
Being receptive to feedback, willingness to learn, and open to continuous improvement.
Embrace and support Operational Excellence Culture and Initiatives.
Wear appropriate Personal Protective Equipment including PAPR (Powered Air Purifying Respirator).
Occasionally, transport materials using manual and power assisted vehicles including manually pushing and pulling drums, totes, boxes, and pallets.
Lift and maneuver empty drums weighing up to 40 pounds up to five times per day; push and maneuver drums containing product weighing up to 275 pounds up to five times per day.
Must be able to visually inspect tablets and capsules for color consistency, shape, and surface defects as part of GMP requirements.
Perform cleaning and assembly/disassembly on production equipment which may require pulling, pushing, or twisting to remove equipment shields, parts, and panels. Equipment and parts may weigh up to 50 pounds.
Ability to work a 10.5-hour per day, 4-day work week (Monday–Thursday), totaling 40 hours per week, with overtime as required.