Job Description

Clinical Packaging Technician

Summary:

Work as part of a Team to execute clinical packaging and labeling activities, including material, room and equipment staging, execution and documentation of operations, and room clearance and cleaning. Support additional operational activities in support of sampling and material transfer. Performs all tasks related to clinical label printing production. Maintain training and compliance with site safety and quality requirements.

Responsibilities:

• Maintain cGMP and safety training to site requirements
• Follow cGMP and safety requirements in all activities
• Stage materials for operations, handling products with restricted time out of environment requirements
• Set-up, operate, disassemble and clean area equipment
• Perform and document de-packaging, packaging, labeling and sampling activities
• Report potential quality events, non-conformance to GMPs/SOPs when observed
• Ensures that each component or bulk material used in label production is properly identified, not expired, verified throughout processing and corresponds to the written information on the work order before proceeding to the next step.
• Print, inspect, proof, and perform accountability for clinical product labels.
• Process labeling/packaging batch paperwork according to GMP/GDP.
• Verifies before use that equipment calibration date has not been exceeded.
• Maintain label inventory.
• Carries out all the appropriate periodic quality inspections during the printing process to ensure the integrity.
• Clean facility and equipment including cleaning of packaging rooms and general housekeeping and perform verification procedures
• Stocking of PPEs, disinfectants, cleaning wipes and other consumables for the facility and packaging rooms
• Physically capable to don and wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE are essential for the health and safety of employees
• Ability to lift, carry, push, and pull up to 50 lbs
• Requirements:
• Must have 1-2 years working in GMP operations
• Experience in Clinical Supply Packaging Operations preferred
• High School Diploma or GED degree required

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