QA Operations Specialist II - Visual Inspection

PCI Pharma Services seeks a QA Operations Specialist II to oversee visual inspection activities, final product sampling, and quality compliance at its Bedford, New Hampshire manufacturing site. The role involves coordinating cross-functional teams, maintaining inspection schedules, and driving continuous improvement in pharmaceutical production processes.

Responsibilities

• Provide QA oversight and support for visual inspection activities and final product release decisions
• Coordinate with manufacturing, materials management, and project teams to improve inspection procedures and packaging processes
• Perform final product inspection, AQL sampling, labeling review, and retain program maintenance
• Write, review, and approve standard operating procedures related to visual inspection and quality operations
• Initiate and manage quality systems including deviations, events, and corrective actions; train staff on inspection protocols

Requirements

• High school diploma
• Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and ICH guidelines
• Strong organizational skills and meticulous attention to detail
• Visual qualifications: corrected or uncorrected 20/20 vision, color vision, ability to discern product specifications
• Proficiency in Microsoft Office (Word, Excel)
• Excellent written and verbal communication skills
• 3+ years experience in Visual Inspection, Quality Assurance, or Quality Control in pharmaceutical manufacturing (preferred)