Visual Inspection Technician

About the Role

A Visual Inspection Technician in a 503B Outsourcing Facility ensures that compounded pharmaceutical products are accurately prepared and without defects. Visual inspection is a critical post-production evaluation for product defects.

Key Responsibilities

• Perform visual inspection of unlabeled finished drug products.
• Classify observed defects into pre-defined categories.
• Calculate percent defects on inspection results and reconcile components.
• Properly document visual inspection activities on associated compounding records in accordance with procedures, CGMP, and CGDP.
• Label all products following facility and regulatory requirements.
• Perform post-labeling inspections.
• Adhere to FDA 503B guidelines, cGMP standards, and USP requirements.
• Follow established protocols for documentation, reporting, and record-keeping.
• Follow safety protocols, including proper gowning, hand hygiene, and equipment sanitation.
• Participate in routine facility cleaning schedules.
• Report any equipment malfunctions or safety concerns to supervisors.
• Assist other process functions as required.

Requirements & Tech Stack

• Proficient in using a computer and related equipment, including printers and fax machines.
• Able to sit or stand for extended periods.
• Effective communication skills via telephone and email.
• Able to work in a controlled environment.
• Capable of lifting up to 40 pounds as needed.
• 20/20 vision (with or without corrective aids) required for visual inspection.

Qualifications

• Educational Background: High school diploma or equivalent; licensed as a pharmacy technician with the Alabama State Board of Pharmacy.
• Experience: Prior experience in a pharmacy, healthcare, or manufacturing environment, especially in sterile compounding or quality.
• Attention to Detail: Effective organization skills, attention to detail, and the maintenance of precise records.
• Completion of inspection certification.

Key Competencies

• Regulatory Knowledge: Familiarity with FDA, cGMP, and USP <797> guidelines is a strong asset.
• Visual ability to detect defects.
• Collaboration: Works well with cross-functional teams, including quality control, shipping, and pharmacists.
• Regulatory Compliance: Strong understanding of 503B regulations and dedication to following all facility protocols.