Teams at American Regent, Inc.

Leads analytical, microbiology, sterility, environmental monitoring, and laboratory operations supporting sterile pharmaceutical manufacturing and R&D across multiple facilities. Manages testing programs, validation and qualification activities, regulatory and customer audits, laboratory personnel, equipment, investigations, CAPAs, outsourced testing, and compliance with cGMP, GLP, and regulatory requirements. Partners with manufacturing, engineering, regulatory, and quality teams to implement new technologies and improve processes.

Provides real-time quality assurance oversight in pharmaceutical manufacturing and warehouse operations. Responsibilities include batch record review, line clearance, aseptic processing audits, GMP observations, material release, deviation approval, technical document review, and support for CAPAs, investigations, calibration, maintenance, and quality systems. Requires an advanced understanding of pharmaceutical manufacturing, laboratory operations, GMPs, regulatory requirements, and controlled-room procedures.

Facilitates pharmaceutical quality compliance programs across sterile injectable production, laboratories, facilities, engineering, and materials. Responsibilities include managing internal audits, CAPA, customer complaints, gap assessments, inspection readiness, quality metrics, and continuous improvement activities. The role requires applying cGMP and U.S. regulatory requirements, supporting batch release and validation activities, and collaborating cross-functionally across Ohio sites.