Product Inspector

Grifols•Clayton, NC

11d•Onsite

About The Position

The Product Inspector role supports plasma production by scanning and inventorying Source Plasma units and archive samples, visually inspecting plasma units, and removing units that are unsuitable for further manufacturing. Work is performed using the Plasma Management System (SGP) and barcode readers, in accordance with standard operating procedures, quality requirements, and safety standards. The role requires accurate recordkeeping and consistent performance against department throughput and schedule targets. Depending on classification, duties include processing plasma units through production units (PUs), managing sub-shipments and reject inventory, blocking units that do not meet customer requirements, recording abnormalities, printing labels, and completing line clearances. Certified inspectors also perform secondary verifications and end-of-line clearances. Employees may cross-train in Material Handling. Work takes place in a manufacturing environment and includes exposure to biological fluids, chemicals, electrical manufacturing equipment, hand tools, moving machinery, high noise, and extreme cold below 32 degrees. The job involves prolonged standing and walking, frequent hand and foot movements, bending and twisting, and lifting and carrying loads up to 50 pounds. Personal protective equipment is required.

Requirements

High school diploma or equivalent.
For the Certified Inspector classification, two years of experience in manufacturing, pharmaceutical, or another FDA-licensed industry is required.
For the Associate Inspector classification, one year of experience in manufacturing, pharmaceutical, or another FDA-licensed industry is desirable.
Knowledge of cGMPs and industry standards; experience is desirable for Associate Inspectors.
Ability to read, understand, interpret, and follow Standard Operating Procedures and oral and written instructions.
Good verbal and written communication skills.
Basic math skills, including addition, subtraction, division, and multiplication.
Basic computer skills and ability to navigate Microsoft Word, Excel, Outlook email, Microsoft Teams, and file management.
Exceptional attention to detail and ability to maintain accurate records.
Ability to work with minimal supervision and consistently meet production throughput standards.
Ability to make fast, simple hand and arm movements to maintain production pace.
Ability to listen to, understand, and communicate information and ideas.
Ability to perform the physical activities described, including standing and walking for 6–8 hours per day, frequent hand and foot movements, bending and twisting, and lifting and carrying up to 50 pounds.
Hearing acuity is essential; color perception/discrimination, depth perception, and far vision must meet the stated visual requirements, with correction permitted as described.

Nice To Haves

For the Associate Inspector classification, one year of experience in manufacturing, pharmaceutical, or another FDA-licensed industry.
For the Associate Inspector classification, experience working with cGMPs and industry standards.
For the Associate Inspector classification, experience reading, understanding, and following Standard Operating Procedures.

Responsibilities

Scan and inventory plasma units assigned to a production unit using a barcode reader.
Scan archive sample vials assigned to a Sample Archive using a barcode reader.
Visually inspect plasma units and remove units that are unsuitable, including units with damage, broken ports or tubes, RBC, or other rejection conditions.
Remove unsuitable plasma units marked for removal in SGP during the production process.
Identify and block units that fail to meet customer requirements.
Identify unreleased units and transfer them into sub-shipments during the PU process.
Verify sub-shipment identification and location at the end of the PU process.
Print or reprint labels using SGP as necessary.
Identify and enter abnormalities into SGP using the Statistics function.
Clear the production line of materials from a completed PU before starting the next PU.
Monitor plasma time out of the freezer and ensure it does not exceed the allowable time, using the SGP warning system.
Complete partial PU cases between production units.
Maintain cGMP compliance through cleanliness, organization, housekeeping, and safety practices.
Maintain record accountability and accuracy, and follow written procedures with minimal supervision.
Process unsuitable plasma units during any step of the plasma process and transfer status 100 units to the correct reject inventory.
Transfer units between PU/LOT and a PU, and scan cases or units for third-party sales and MDO processes using the Disposition Module.
Meet department throughput standards consistently.
Perform secondary verifications and end-of-PU-line clearances as required for the Certified Inspector role.
Operate forklifts, tractors, and power equipment as required.
Cross-train in Material Handling to support efficient plasma operations.