Senior Quality Engineer - Inspection

Responsibilities

• Provide quality oversight and subject matter expertise for visual inspection operations supporting sterile injectable products
• Support manual, semi-automated, and automated inspection processes for vials, syringes, and cartridges
• Develop and maintain inspection-related quality systems in compliance with FDA, EMA, and global GMP requirements
• Lead investigations related to inspection defects, particulate findings, reject trends, and quality events
• Support CAPAs, root cause analysis activities, and continuous improvement initiatives tied to inspection performance
• Collaborate with Manufacturing, Engineering, and Technical Services teams to establish inspection parameters and defect classification standards
• Support development of AQL sampling plans, defect libraries, and inspection qualification activities
• Review and approve SOPs, batch record documentation, validation protocols, and risk assessments related to visual inspection operations
• Ensure inspection programs maintain audit and inspection readiness for regulatory agencies and client audits
• Provide QA floor support and escalation management during commercial manufacturing and inspection activities
• Stay current on evolving industry standards and advancements in automated visual inspection technologies

Qualifications

• 5+ years of experience within pharmaceutical or biotech Quality Assurance environments
• Direct experience supporting visual inspection operations for sterile injectable or parenteral products
• Strong knowledge of manual and automated inspection methods, defect classification systems, and AQL sampling practices
• Experience supporting GMP investigations, deviations, CAPAs, and change controls within a regulated manufacturing environment
• Familiarity with FDA regulations, EU GMP Annex 1, USP <790>/<1790>, and related inspection guidance documents
• Experience supporting FDA, EMA, or client audits and maintaining inspection readiness
• Background in sterile manufacturing, aseptic processing, biologics, or injectable products preferred
• Strong communication and cross-functional collaboration skills