Operations Visual Inspector Tier I

Job Purpose: The Production Visual Inspector is responsible for performing visual inspection activities for injectable and ophthalmic pharmaceutical products in compliance with company policies and procedures, FDA regulations, and current Good Manufacturing Practices (cGMP). This role supports production and packaging operations while maintaining accurate documentation, ensuring product quality, and promoting a safe and compliant work environment. 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: High school diploma or GED required; Associate degree or Bachelor’s degree in a scientific or technical field preferred. Experience working with ophthalmic, sterile, injectable, or parenteral products preferred. Knowledge of cGMP regulations, GDP documentation practices, and FDA pharmaceutical manufacturing requirements preferred. Ability to identify visual defects and maintain visual acuity and visual inspection qualification standards required. Experience working in controlled manufacturing environments preferred. Strong attention to detail, manual dexterity, and ability to maintain concentration during repetitive inspection activities required. Working Conditions / Physical Requirements: Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, sitting, typing, and walking. Ability to maintain concentration during repetitive inspection activities required. #J-18808-Ljbffr