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QA Production Oversight

Position Overview

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, ensuring compliant execution of sterile production activities and timely escalation of quality risks.

About the Role

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.

 

Requirements

  • Sc. in Life Sciences, Biotechnology, Biology, Microbiology, Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline – Must.
  • Additional GMP, aseptic processing, contamination control, or quality systems training – Must.
  • 5+ years of QA, production, or quality oversight experience in sterile pharmaceutical manufacturing.
  • Practical GMP experience in cleanrooms, aseptic processing, batch documentation, line clearance, deviations, CAPA, and production-floor investigations.
  • Good understanding of contamination control, EM, gowning practices, cleanroom behavior, aseptic interventions, and data integrity principles.
  • Ability to work independently on the production floor, make risk-based decisions, and escalate issues appropriately.

    Apply