Product Inspector (2nd shift) 1

About the role

Position requires scanning and removal of unsuitable plasma units utilizing the Plasma Management System (SGP). A visual inspection of plasma units is also performed, removing any units which are unacceptable (e.g. damaged, broken port/tube, RBC, or backup sample rejections). Employee must be able to perform secondary verifications and perform end of PU line clearances.

Responsibilities

• Scanning of plasma units assigned to a PU utilizing a barcode reader
• Scanning of archive samples assigned to a SA utilizing a barcode reader
• Transferring units to a Sub-shipment during the PU process
• Entering "Statistics" during the PU process
• Sub-shipment verification at the end of the PU process
• "Blocking" of units which do not meet customer requirements
• Responsible for various rejections found during visual inspection
• Removal of unsuitable plasma units marked for removal in SGP during the PU process
• Able to maintain record accountability
• Able to perform job duties with minimum supervision
• Ability to follow written procedures
• Monitoring plasma time out of freezer
• Department housekeeping and safety practices
• Processing of unsuitable plasma units during any step of the plasma process
• Transfer of unsuitable plasma units (status 100) to correct reject inventory
• Transferring units between PU/LOT to a PU
• Ability to consistently meet department average throughput
• Knowledge of SGP Status codes and Disposition Codes
• Knowledge of labeling Requirements
• Scanning of case/units to a 3rd party sale utilizing Disposition Module
• Scanning of case/units to a MDO process utilizing Disposition Module
• Completing the partial PU cases between PU's
• Line Clearance at the end of a Plasma Process

Requirements

• High School diploma or equivalent
• Two years' experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable
• Knowledge of cGMPs and Industry Standards
• Ability to follow "Standard Operating Procedures"
• Possess good verbal and written communication skills
• Possess basic math skills (addition, subtraction, division, multiplication)
• Basic Computer skills

Occupational Demands

• Work is performed in a manufacturing environment with rotating shifts
• Exposure to biological fluids with potential exposure to infectious organisms
• Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery
• Exposure to high levels of noise and to extreme cold below 32*
• Occasional entry into confined spaces requiring kneeling and squatting
• Operates forklifts, tractors and power equipment
• Personal protective equipment required such as protective eyewear, safety shoes, gloves and garments
• Work is performed standing and walking for 6-8 hours per day
• Bending and twisting neck and waist for 6-8 hours per day
• Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists
• Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects
• Frequent foot movement
• Frequent moderate lifting and carrying of 15-44lbs
• Frequent heavy lifting and carrying of 45lbs with a maximum lift of 50lbs
• Occasionally reaches above and below shoulder height
• Hearing acuity essential
• Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences
• Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures

Location: NORTH AMERICA : USA : NC-Clayton : USNC0002 - Clayton