QA Manufacturing Specialist

Responsibilities

• Provide Quality oversight of Production activities including compounding, aseptic filling, inspection, and labeling/packaging
• Oversee cleaning activities to ensure compliance with requirements
• Perform product label review and approval
• Confirm compliance with Filling Operations, including line clearance, material status, and aseptic technique
• Verify proper gowning by all personnel in Production areas
• Generate deviations, issue CAPAs, and manage Change Controls
• Participate in regulatory audits and assist with root cause analysis

Requirements

• 3-5 years of progressive experience in cGMP quality operations and FDA regulations
• Experience in a 503B outsourcing facility or aseptic/parenteral manufacturing environment
• High school degree required; BS in a scientific field preferred
• Three-plus years of experience with aseptic drug product manufacturing
• Working knowledge of safety, quality systems, and Good Documentation Practices
• Strong familiarity with manufacturing processes, automation, and equipment
• Proficiency in Microsoft Office (Word, PowerPoint, Excel)
• Ability to work the 2nd shift (3pm - 1:30am)

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.