QA Operations Specialist I - Visual Inspection

PCI Pharma Services seeks a QA Operations Specialist I to support visual inspection and final product sampling, packaging, and shipment activities at its Bedford, NH facility. The role involves maintaining inspection standards, coordinating with cross-functional teams, and driving continuous improvement in quality assurance processes.

Responsibilities

• Provide QA oversight and support for visual inspection activities and final product sampling
• Inspect final packaged lots, bulk packaging, perform AQL inspections, and manage product disposition
• Create, review, and approve final product shipper and vial labels
• Initiate and own quality system activities including events, deviations, and CAPAs
• Train and qualify new staff; maintain Standard Operating Procedures and continuous improvement efforts

Requirements

• High school diploma
• Knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and ICH guidelines
• Strong organizational skills and attention to detail
• Corrected or uncorrected 20/20 vision, color vision, and ability to discern product specifications
• Proficiency in MS Office (Word, Excel)
• Excellent verbal and written communication skills
• Ability to work in dynamic, fast-paced environment