Packaging

Summary:

• 2nd Shift - 4:00pm – 2:30am (Mon - Thurs)

Responsibilities:

• 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.

Physical and Environmental:

• Occasionally move/traverse, ascend/descend step ladders, stairs, and/or platforms.
• 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.