We are looking for a hands-on QA Production Oversight professional to provide real-time GMP oversight on the production floor in a sterile manufacturing environment. This is a shift-based role focused on ensuring compliant execution of sterile production activities and timely escalation of quality risks.
Key Responsibilities
• Provide on-the-floor QA oversight during sterile manufacturing activities, including aseptic processing, filling, filtration, cleaning, set-up, line clearance, and routine production
• Ensure real-time compliance with approved batch records, SOPs, GMP requirements, aseptic practices, gowning, material/personnel flow, and contamination control expectations
• Review and verify GMP documentation during the shift, including batch records, logbooks, forms, line clearance records, equipment status, and critical process entries for accuracy, completeness, and data integrity
• Identify, assess, document, and escalate quality events, deviations, documentation errors, process anomalies, EM concerns, and potential contamination risks in real time
• Support deviation initiation, impact assessment, containment actions, investigation inputs, CAPA follow-up, and batch-related quality decisions with Production and QA management
• Observe and challenge aseptic interventions, cleanroom behavior, line practices, material handling, equipment use, and adherence to contamination control requirements
• Participate in shift handovers, production meetings, and escalation discussions to maintain continuity of quality oversight across shifts
• Support media fills, qualification/validation batches, engineering or maintenance interventions, and production readiness activities from a QA perspective
• Promote shop-floor quality culture and audit readiness through GMP coaching, documentation discipline, aseptic conduct, and right-first-time execution