Quality Applications Specialist

The Quality Application Specialist supports product transfer activities with a primary focus on process validation, sterilization processes, and commercial release readiness. This role ensures compliant execution of validation activities and quality system requirements in alignment with FDA and international regulations. The position requires strong experience in sterilization, final packaging validation, statistical analysis, and risk management methodologies to support First Time Quality initiatives and successful product transfers. Responsibilities: Support product transfer from development to commercial manufacturing. Execute and document validation lifecycle activities (IQ/OQ/PQ). Develop validation protocols, reports, and risk assessments. Perform Process Failure Mode and Effects Analysis (pFMEA). Conduct statistical analysis to evaluate process capability and performance. Support sterilization validation activities (EO, steam, radiation preferred). Oversee Final Packaging valida...