Product Inspector

GRIFOLS, S.A.•NC-Clayton, CA

13d•Onsite

About The Position

The Product Inspector role is presented with responsibilities and qualifications for Associate Inspector, Certified Inspector, and Classification Inspector work. The position involves scanning and inventorying plasma units and archive samples with barcode readers, visually inspecting plasma, and removing units that are unsuitable for further manufacturing. Work is performed using the Plasma Management System (SGP) and according to written procedures, quality requirements, and safety standards. Employees are expected to maintain accurate records, meet department throughput standards, and preserve cleanliness and organization in a manufacturing environment. The schedule listed is 1st shift, Monday through Friday, 5:00 a.m. to 1:30 p.m. The position is located in Clayton, North Carolina. Occupational conditions include exposure to biological fluids and potential infectious organisms, chemicals, electrical manufacturing equipment, hand tools, moving machinery, high noise, and temperatures below 32°F. The role requires personal protective equipment and may involve occasional entry into confined spaces.

Requirements

High school diploma or equivalent.
For Certified Inspector: two years of experience in manufacturing, pharmaceutical, or another FDA-licensed industry.
For Associate Inspector: one year of experience in manufacturing, pharmaceutical, or another FDA-licensed industry is desirable.
Knowledge of cGMPs and industry standards; desirable for Associate Inspector and specified for Certified Inspector.
Ability to read, understand, and follow Standard Operating Procedures and other written procedures.
Good verbal and written communication skills.
Basic math skills, including addition, subtraction, division, and multiplication.
Basic computer skills and ability to use Microsoft Word, Excel, Outlook email, and Microsoft Teams, and understand file management.
Ability to listen to and understand spoken information and follow oral and written instructions.
Exceptional attention to detail and ability to maintain record accuracy and accountability.
Ability to make fast, simple hand and arm movements to maintain production pace and meet standards.
Ability to perform duties with minimal supervision and meet department throughput expectations.
Ability to perform required physical activities, including standing and walking for 6–8 hours per day; bending and twisting the neck and waist for 6–8 hours per day; frequent hand and foot movements; and frequent moderate lifting and carrying of 15–44 pounds and heavy lifting and carrying of 45 pounds, up to a maximum lift of 50 pounds.
Ability to occasionally reach above and below shoulder height and occasionally enter confined spaces requiring kneeling and squatting.
Hearing acuity is essential; visual abilities include color perception/discrimination, depth perception, and far vision correctable in one eye to 20/30 and in the other eye to 20/100.
Ability to communicate information and ideas so others understand, and to listen to and understand information and ideas.

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 a production unit (PU) using a barcode reader.
Scan archive sample vials assigned to a Sample Archive (SA) using a barcode reader.
Visually inspect plasma units and identify and remove units that fail rejection criteria or are otherwise unsuitable.
Remove plasma units marked for removal in SGP and process unsuitable units during any step of the plasma process.
Identify and block units that do not 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 needed.
Enter abnormalities into SGP using the Statistics function during or after the PU process.
Clear the production line of material from a completed PU before starting the next PU process, including end-of-process line clearance.
Monitor plasma time out of the freezer and ensure it does not exceed the allowable time.
Complete partial PU cases between PUs.
Maintain cGMP compliance through cleanliness, organization, housekeeping, and safety practices.
Maintain record accountability and accuracy, and follow written procedures with minimal supervision.
Transfer unsuitable plasma units (status 100) to the correct reject inventory and transfer units between PU/LOT to a PU.
Scan cases or units for third-party sales and MDO processes using the Disposition Module.
Meet department throughput standards and production targets consistently.
Perform secondary verifications and end-of-PU line clearances as required for Certified Inspector duties.
Cross-train in the Material Handling department as needed to support efficient plasma operations.