Product Inspector

GRIFOLS, S.A.•NC-Clayton, CA

1d•Onsite

About The Position

Grifols is hiring for a plasma classification and inspection role, with Associate Inspector and Certified Inspector responsibilities. The position involves scanning and inventorying plasma units and archive samples using barcode readers and the Plasma Management System (SGP), visually inspecting plasma, and removing or processing unsuitable units according to rejection criteria and customer requirements. Work must follow Standard Operating Procedures, cGMPs, quality and safety standards, and recordkeeping requirements, while meeting department throughput standards. The role also includes production-unit and shipment tasks such as transferring and verifying units, blocking units that do not meet requirements, recording abnormalities, printing labels, monitoring plasma time out of the freezer, and clearing the line at the end of a process. Employees may cross-train in Material Handling. The work is performed in a manufacturing environment and requires rotating shifts. The listed schedule for this posting is Monday through Thursday, 1:30 p.m. to 12:00 a.m.

Requirements

High school diploma or equivalent.
For Certified Inspector: two years of experience in manufacturing, pharmaceutical, or another FDA-licensed industry.
For Certified Inspector: knowledge of cGMPs and industry standards.
Ability to read, understand, and follow written procedures and oral instructions.
Basic arithmetic skills, including addition, subtraction, division, and multiplication.
Basic computer skills; ability to navigate Microsoft Word and Excel, use Outlook and Microsoft Teams, and understand file management.
Good verbal and written communication skills for the Certified Inspector role.
Ability to maintain accurate records and perform duties with minimal supervision.
Ability to listen to and understand spoken information and instructions.
Ability to make fast, simple hand and arm movements to maintain production pace.
Exceptional attention to detail.
Ability to meet department throughput standards.
Ability to work in a manufacturing environment with exposure to biological fluids and potential infectious organisms, chemicals, electrical manufacturing equipment, hand tools, moving machinery, high noise levels, and temperatures below 32 degrees.
Ability to work standing and walking for 6–8 hours per day and bend and twist the neck and waist for 6–8 hours per day.
Frequent hand and foot movement; ability to make precise, coordinated finger movements to grasp and manipulate objects.
Ability to lift and carry 15–44 pounds frequently and 45 pounds frequently, with a maximum lift of 50 pounds; occasional reaching above and below shoulder height.
Hearing acuity; color and depth perception; and far vision correctable to 20/30 in one eye and 20/100 in the other eye.
Ability to communicate information and ideas and to understand information and ideas communicated by others.

Nice To Haves

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

Responsibilities

Scan and inventory plasma units assigned to production units using a barcode reader.
Visually inspect plasma units and identify and remove units that meet rejection criteria or are otherwise unsuitable.
Remove units designated for removal in SGP and block units that fail customer requirements.
Identify unreleased units and transfer them into sub-shipments; verify sub-shipment identification and location at the end of the production-unit process.
Print or reprint labels using SGP.
Identify and enter abnormalities in SGP using the Statistics function.
Clear the production line of materials from a completed production unit before starting the next process, including end-of-process line clearance.
Monitor plasma time out of the freezer using the SGP warning system.
Scan archive sample vials assigned to a Sample Archive using a barcode reader.
Complete partial production-unit cases between production units.
Maintain cGMP compliance through cleanliness, organization, housekeeping, and safe work practices.
Maintain accurate and accountable records and follow written procedures, working with minimal supervision while meeting throughput standards.
Cross-train in Material Handling to support efficient plasma operations.
Transfer unsuitable units to the correct reject inventory and process unsuitable plasma units as required.
Transfer units between production units or lots, and scan cases or units for third-party sales or MDO processes using the Disposition Module.
Follow labeling requirements and use SGP status and disposition codes.
Perform secondary verifications and end-of-production-unit line clearances as required for certified inspectors.