Supervisor, Quality Control Aseptic
$75,000–$116,250 year
On-site · West Chester, Ohio, United States
Job Summary
The Supervisor, Quality Aseptic Control will lead a 24/7 night-shift team of Aseptic Control Leads and Technicians, executing environmental monitoring and aseptic control activities in alignment with the site strategy and aseptic strategy. Responsible for maintaining cGMP/SOX/EHS compliance, delivering QC and site Quality priorities, and developing a high-performing team. Responsibilities include training staff, reviewing production and lab documentation for quality and compliance, addressing deviations and investigations, communicating policies, leading process-improvement initiatives, and ensuring staff have tools and training to perform safely. The role requires coordinating with regulatory agencies as needed, and providing ongoing progress updates to the team while supporting Environmental Monitoring, Operations, or Laboratory processes as needed. The position is night shift (6 PM–6:30 AM) with a rotating 2/2/3 schedule. Sponsorship for work authorization is not available. The organization emphasizes GMP compliance, quality systems, and LEAN manufacturing principles, with opportunities to drive improvements and support for maintaining regulatory readiness.
Required Qualifications
- Bachelor’s degree in engineering, pharmacy, or a related science or business
- Strong communication and leadership skills
- Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, or change control
- Experience in production or quality control environment
- LEAN manufacturing experience
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