Quality Assurance Inspector

Responsibilities

• Perform QA oversight of Production activities including Compounding, Filling, Inspection, Labeling and Packing
• Oversee and confirm cleaning of rooms, parts, equipment, and surfaces for compliance
• Confirm compliance in Compounding processes including room clearance, material status, weighing, and mixing
• Oversee Filling Operations including line clearance, aseptic technique, and in-process quality attribute testing
• Verify proper gowning by all personnel in Production areas
• Verify environmental monitoring activities including plating and personnel monitoring
• Sample, inspect, and tag incoming raw materials and components
• Review and approve product labels
• Participate in regulatory audits and assist with root cause analysis

Requirements

• 1-3 years of progressive experience in cGMP quality operations or FDA/503B outsourcing facilities
• 1+ years of experience with aseptic drug product manufacturing
• High school degree required; BS in a scientific field preferred
• Working knowledge of safety, quality systems, and Good Documentation Practices (GDP)
• Familiarity with manufacturing processes, automation, and equipment validation
• Strong computer skills in Word, PowerPoint, and Excel
• Ability to work under pressure and meet deadlines
• Flexibility to work rotating shifts, holidays, and weekends as needed

About the Company

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, specializing in a comprehensive portfolio of retina, dry eye, and surgical products.