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. Oversee Final Packaging validation and verification processes. Ensure processes meet regulatory and compliance requirements (FDA, GMP). Collaborate cross-functionally with Manufacturing, Engineering, and Quality teams. Provide validation status updates and support audit readiness activities. Drive First Time Quality improvements and continuous process optimization. *Other duties may be assigned.* Requirements Required Qualifications: Bachelor’s Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related). 3–6 years of experience in Quality, Validation, or Product Transfer roles. Hands-on experience with sterilization processes. Experience in Final Packaging validation. Strong knowledge of IQ/OQ/PQ validation execution. Experience with statistical analysis tools (Minitab preferred). Experience performing pFMEA and risk assessments. Working knowledge of FDA regulations and GMP requirements. Top 3 Critical Experience Areas (Must Have) Knowledge of Sterilization Processes Knowledge in Final Packaging Process Validation, Statistical Analysis, pFMEA & First Time Quality #J-18808-Ljbffr