Sr. QA Operations Specialist - Visual Inspection

Senior QA Operations Specialist responsible for overseeing visual inspection activities, product sampling, and packaging operations at a pharmaceutical manufacturing site in Bedford, NH. The role supports compliance with FDA and international regulations while coordinating with cross-functional teams on quality assurance and continuous improvement initiatives.

Responsibilities

• Provide QA oversight and support for visual inspection activities and final product sampling
• Coordinate with cross-functional teams to improve visual inspection procedures, labeling, and packaging
• Perform final packaged lot inspection, AQL sampling, and final product disposition functions
• Initiate and manage quality systems including deviations, events, and corrective actions
• Train and qualify new staff; maintain training and qualification records for all team members

Requirements

• High school diploma minimum
• Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and international standards
• Strong organizational skills, attention to detail, and scientific aptitude
• Annual visual qualification: 20/20 vision (corrected or uncorrected), color vision, product specification discernment
• Proficiency in Microsoft Office (Word, Excel) and excellent written/verbal communication
• 5+ years experience in visual inspection, QA, or QC in pharmaceutical manufacturing preferred