Plasma Classification Certified Inspector

Grifols, S.A; Clayton (NC); Hybrid; USD 52,000 - 76,000; Full time

Job summary

Grifols is seeking a Plasma Classification Certified Inspector for 1st Shift (Mon-Fri, 5:00am-1:30pm) to support plasma unit screening, inspection and disposition in a GMP environment. Responsibilities include barcode scanning, unit transfer, and end-of-process verifications to ensure accurate inventory and compliance.

The role requires a high school diploma and 2 years’ experience in a FDA-regulated setting, with solid knowledge of SOPs, cGMP, and strong communication.

Qualifications

• Two years’ experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is required.
• Knowledge of cGMPs and Industry Standards.
• Ability to follow Standard Operating Procedures.
• Possess good verbal and written communication skills.
• Possess basic math skills.

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.

Education

High School diploma or equivalent

Job description

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Plasma Classification Certified Inspector

1st Shift - Monday - Friday 5:00am - 1:30pm

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 SGPduring 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 required.
• 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).

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.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.