Quality Inspection Lead

JOB TITLE: Quality Visual Inspection Lead

JOB LOCATION: Fargo, ND, 58104 (Onsite Position)

Contract Duration: 06 months

Note: Candidate must have 20/20 vision and no color blindness

JOB DESCRIPTION:

•           The GMP Visual Inspector performs 100% manual visual inspection of filled and sealed drug product vials. Using a controlled inspection booth, standardized lighting, and approved techniques, the inspector evaluates each vial for visible particulate matter and container, closure, fill, and cosmetic defects. Nonconforming units are removed, uncertain conditions are escalated, and inspection results are documented when the work is performed.

•           This is a dedicated, full-time inspection role. Previous pharmaceutical or visual inspection experience is not required. Success depends on patience, concentration, consistency, visual attention, and willingness to follow a defined method every time. Structured training and qualification are provided.

What to Expect

•           This is focused, repetitive, precision work. Inspectors spend much of the shift examining small glass vials under controlled lighting, with required eye breaks built into the process. Some training products are clear and straightforward. Most will be opaque, colored, or visually challenging. Accuracy is more important than speed.

•           Work in a quiet, controlled environment where distractions are minimized.

•           Use the same approved inspection technique consistently throughout the shift.

•           Reject defects and route uncertain conditions for further evaluation rather than guessing.

•           Handle high-value drug product carefully and maintain accurate reconciliation and documentation.

Key Responsibilities

• Complete required GMP, GDP, safety, procedure, defect-recognition, and inspection-technique training.

• Successfully complete initial qualification before independently inspecting GMP product and maintain active qualification status.

• Perform 100% manual visual inspection of assigned filled and sealed vials using approved lighting, backgrounds, handling technique, and inspection timing.

• Identify and document visible particles, fibers, fill-volume concerns, container or closure defects, scratches, scuffs, discoloration, and other defined defects.

• Segregate rejected units and units requiring further evaluation while maintaining clear material status and chain of custody.

• Record inspection results accurately and contemporaneously in accordance with GDP requirements.

• Follow required inspection intervals, eye breaks, area controls, gowning, hygiene, and product-handling requirements.

• Support reconciliation of inspected, accepted, rejected, and further-evaluation units.

• Participate in refresher training, requalification, defect-kit activities, and continuing inspection practice as assigned.

• When inspection demand is lower, support approved Drug Product activities such as training, area readiness, defect-kit preparation, inventory, documentation support, or continuous improvement within the employee’s training and authorization.

Minimum Qualifications

• High school diploma or GED.

• Ability to read and understand written procedures, follow step-by-step instructions, and complete clear, accurate records in English.

• Basic math skills sufficient for counts, reconciliation, and simple calculations.

• Ability to maintain sustained attention during repetitive, detail-oriented work.

• Reliable attendance and ability to work the assigned first- or second-shift schedule.

• Ability to meet role-specific visual requirements, including 20/20 near visual acuity with or without corrective lenses and the ability to distinguish required colors, as confirmed through the applicable eye examination.

• Ability to handle small glass vials safely and perform fine visual and manual work during scheduled inspection periods.

Preferred Qualifications

Prior experience is not required. Experience in pharmaceutical, medical-device, laboratory, electronics, precision assembly, quality inspection, manufacturing, or other detail-oriented work may be helpful.