Aseptic Manufacturing Monitor

The Aseptic Manufacturing Oversight Associate 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.

• 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.

• 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.

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

• Bachelor’s degree in biological sciences or engineering preferred, or equivalent education/experience.

• Minimum 2 years in a QA role within a GMP pharmaceutical or biotech manufacturing environment.
• Strong understanding of biotechnology manufacturing (e.g., sterilization, aseptic processing).
• Solid knowledge of GMP, data integrity, manufacturing operations, and contamination control principles.
• Strong communication, problem-solving, and decision-making skills.
• Ability to remain calm, objective, and effective in fast-paced environments.
• High attention to detail and commitment to product quality, patient safety, and compliance.
• Ability to collaborate cross-functionally while maintaining independence in quality decisions.

• Ability to sit and stand for extended periods.
• Ability to stand and/or walk on concrete floors for 8–10 hours per day.
• Ability to move safely within manufacturing environments, including donning appropriate PPE within classified clean rooms and wearing required PPE (gowning, safety eyewear, gloves, etc.).
• Ability to lift or maneuver materials or equipment up to 25 lbs as required.