Operations Visual Inspector Tier I

Essential Duties and Responsibilities

• Perform 100% visual inspection of ophthalmic and parenteral drug products, including vials, syringes, ampoules, bottles, and IV bags, in accordance with cGMP requirements and approved inspection procedures
• Inspect products for particulate matter, cosmetic defects, container closure integrity defects, fill level discrepancies, discoloration, cracks, chips, leaks, and other non-conformances
• Execute manual and semi-automated visual inspection activities while maintaining inspection qualification standards and inspection rate requirements
• Maintain compliance with current Good Manufacturing Practices (cGMP), FDA regulations, SOPs, batch records, and data integrity requirements
• Document inspection activities accurately and contemporaneously in batch records, logbooks, and electronic system
• Support line clearance, room setup, and inspection area readiness activities prior to production operations
• Identify, segregate, and report defective or non-conforming materials in accordance with quality procedures
• Participate in initial and annual visual inspection qualification and requalification programs, including defect kit training and certification activities
• Support investigations related to visual defects, deviations, complaints, and non-conforming product events
• Collaborate with Manufacturing, Quality Assurance, and Quality Control teams to ensure product quality and inspection compliance
• Assist with cleaning and sanitization of inspection equipment and work areas in controlled manufacturing environments
• Support continuous improvement initiatives related to inspection processes, defect reduction, and operational efficiency
• Participate in regulatory inspection readiness activities and provide documentation support during audits and inspections
• Follow all safety, gowning, contamination control, and aseptic behavior requirements while working in classified manufacturing environments

Education / Experience

• A high school diploma or GED is required; an associate degree or bachelor’s degree in a scientific or technical field is preferred
• Experience working with ophthalmic, sterile, injectable, or parenteral products is preferred
• Knowledge of cGMP regulations, GDP documentation practices, and FDA pharmaceutical manufacturing requirements is preferred
• The ability to identify visual defects and maintain visual acuity and visual inspection qualification standards is required
• Experience working in controlled manufacturing environments is preferred
• A strong attention to detail, manual dexterity, and ability to maintain concentration during repetitive inspection activities are required

Working Conditions / Physical Requirements

• The position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking
• The ability to maintain concentration during repetitive inspection activities is required