Remote Quality Complaint Specialist

Job Summary

Supporting the Product Quality Complaint program, the part-time Remote Quality Complaint Specialist will manage complaint investigations, coordinate with stakeholders, and ensure compliance with regulatory requirements in a fully remote setting.

Key responsibilities

• Support the product complaint program from intake to closure, ensuring compliance with GMPs
• Conduct and draft investigations related to drug product manufacturing and packaging, including reviewing relevant documentation
• Coordinate with contract manufacturers and internal teams to resolve technical questions and obtain necessary investigation information

Required qualifications

• Bachelor's Degree in any field
• Experience in aseptic manufacturing (preferred)
• Experience independently investigating pharmaceutical product complaints and preparing investigation reports (preferred)
• Experience with sterile ophthalmic products and packaging defects (preferred)
• Knowledge of Microsoft Office Systems