Product Inspector

Grifols, S.A; Clayton (NC); On-site; USD 25,000 - 36,000; Full time

Job summary

Grifols, S.A. is seeking a Plasma Classification Associate / Certified Inspector for 2nd shift in Clayton, NC. The role involves scanning plasma units, performing visual inspection, and removing units that do not meet quality standards.

Candidates must follow SOPs and maintain accurate records in a GMP environment. The Associate Inspector and Certified Inspector responsibilities include ensuring unit accuracy, completing PU process steps, and maintaining strict production timelines within a

Qualifications

• High School diploma or equivalent required; FDA/CGMP familiarity desirable.
• Ability to read and follow standard operating procedures precisely.
• Ability to maintain accuracy and record accountability.

Responsibilities

• Scan plasma units using barcode reader and inventory within PU.
• Identify and remove units according to rejection criteria during inspection.
• Ensure plasma units do not exceed time-out of freezer and complete PU process.
• Maintain cGMP compliance, cleanliness, and proper documentation.

Skills

Basic math skills

Reading SOPs

Verbal and written communication

Following procedures

Attention to detail

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 Associate / Certified Inspector

2nd Shift - Monday - Thursday 1:30pm – 12:00am

Summary:

Associate Inspector:

This position requires scanning of Source Plasma units and removal of unsuitable units utilizing the Plasma Management System (SGP). Functions are performed according to specific Standard Operating Procedures, quality, and safety standards and insuring accuracy. A visual inspection of plasma units is also performed, to remove any units which are unacceptable for further manufacturing (e.g. damaged, broken port/tube, RBC, or removal rejections). Throughput Standards and Schedule Targets should be met consistently.

Certified Inspector:

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.

Experience:

• 1. High School Diploma or equivalent.
• 2. One year experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is desirable.
• 3. Experience working with cGMPs and Industry Standards desirable.
• 4. Experience in reading, understanding, and following Standard Operating Procedures desirable.

Certified Inspector:

• 1. High School diploma or equivalent.
• 2. Two years’ experience in Manufacturing, Pharmaceutical or other FDA licensed Industry is required.
• 3. Knowledge of cGMPs and Industry Standards.
• 4. Ability to follow “Standard Operating Procedures”.
• 5. Possess good verbal and written communication skills.
• 6. Possess basic math skills (addition, subtraction, division, multiplication).

Responsibilities:

Associate Inspector:

• 1. Responsible for scanning and inventorying plasma units assigned to a production unit (PU) utilizing a barcode reader.
• 2. Responsible for identifying and removing units according to various rejection criteria found during visual inspection.
• 3. Responsible for removal of unsuitable plasma units marked for removal in SGP during the PU process.
• 4 Responsible for identifying and blocking units from further production when units fail to meet customer requirements.
• 5, Responsible for identifying unreleased units and transferring those units into sub shipments during the PU process.
• 6. Responsible for verification of sub-shipment identification and location at the end of the PU process.
• 7. Print/reprint labels as necessary utilizing SGP
• 8. Responsible for identifying and entering abnormalities into SGP via the “Statistics” function, during or after the PU process.
• 9. Responsible for clearing the production line of all material processed in a completed PU before starting the next PU process.
• 10. Responsible for ensuring plasma does not exceed the allowable time out of freezer during production, utilizing the SGP warning system.
• 11. Responsible for scanning of archive samples vials assigned to a Sample Archive (SA) utilizing a barcode reader.
• 12. Responsible for completing the partial PU cases between PUs
• 13. Responsible for maintaining cGMP compliance by ensuring a high level of cleanliness and organization.
• 14, Required to interpret and follow written procedures.
• 15. Must maintain record accountability and demonstrate accuracy.
• 16. Job duties should be performed with minimal supervision while consistently meeting department throughput standards.
• 17. Ability to cross train in the Material Handling department to ensure efficient plasma operations.

Classification Inspector:

• 1. Scanning of plasma units assigned to a PU utilizing a barcode reader.
• 2. Scanning of archive samples assigned to a SA utilizing a barcode reader.
• 3. Transferring units to a Sub-shipment during the PU process.
• 4. Entering “Statistics” during the PU process.
• 5. Sub-shipment verification at the end of the PU process.
• 6. “Blocking” of units which do not meet customer requirements.
• 7. Responsible for various rejections found during visual inspection.
• 8. Removal of unsuitable plasma units marked for removal in SGPduring the PU process.
• 9. Able to maintain record accountability.
• 10. Able to perform job duties with minimum supervision.
• 11. Ability to follow written procedures.
• 12. Monitoring plasma time out of freezer
• 13. Department housekeeping and safety practices
• 14. Processing of unsuitable plasma units during any step of the plasma process.
• 15. Transfer of unsuitable plasma units (status 100) to correct reject inventory
• 16. Transferring units between PU/LOT to a PU.
• 17. Ability to consistently meet department average throughput.
• 18. Knowledge of SGP Status codes and Disposition Codes.
• 19. Knowledge of labeling Requirements.
• 20. Scanning of case/units to a 3rd party sale utilizing Disposition Module.
• 21. Scanning of case/units to a MDO process utilizing Disposition Module.
• 22. Completing the partial PU cases between PU’s.
• 23. Line Clearance at the end of a Plasma Process.

Additional Requirements: (Both)

• 1. Possess the ability to listen to and understand information presented through spoken words and sentences. And perform within the guidance of both oral and written instructions.
• 2. Possess basic math skills (addition, subtraction, division, multiplication).
• 3. Navigate and understand Microsoft Word/Excel, using Outlook Email, Microsoft Teams, and understand file management
• 4. Able to make fast simple movements of hands and arms to maintain work pace to meet production standards.
• 5. Exceptional focus to detail.

Occupational Demands: (Both)

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.

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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.