Quality Oversight Specialist

Position Overview

The QA on the Floor Specialist provides real-time quality oversight in aseptic manufacturing areas to ensure operations meet GMP, regulatory, and site quality standards. This role delivers immediate quality support, promotes a strong quality culture, and partners with operations to achieve production goals while maintaining compliance. Responsibilities include proactive issue identification, timely decision support, and reinforcing high standards of quality, data integrity, and compliance.

Key Responsibilities

Quality Oversight & Support

•        Serve as the primary on-the-floor Quality presence in critical manufacturing areas.
•          Provide immediate GMP, documentation, and aseptic behavior guidance to operators and supervisors.
•          Perform real-time review of manufacturing documents (batch records, logbooks, sampling, equipment use) to minimize errors and delays.
•          Release aseptic areas daily following review of cleaning records and room clearance.

Issue Identification & Decision Support

•          Identify and promptly escalate potential risks (e.g., deviations, contamination risks, process issues).
•          Support operations with quality-focused, solution-driven real-time issue triage to maintain product quality and production flow.
•          Ensure rapid, compliant resolution of on-the-floor quality questions.
•          Partner with operations and other teams to support timely, thorough investigations.

Monitoring & Compliance Activities

•          Observe manufacturing activities to ensure consistent application of GMP (ALCOA+) and contamination control strategies.
•          Support internal audits, regulatory inspections, and readiness activities through documentation review, media fills, Gemba walks, and follow-up actions.

Continuous Improvement

•          Identify opportunities to streamline processes while maintaining quality and compliance.
•          Contribute to initiatives that improve documentation accuracy, reduce deviations, and enhance operational excellence.