Teams at American Regent, Inc.

Provide real-time QA oversight of aseptic manufacturing (APA) via in‑person and video monitoring to ensure cGMP compliance. Identify, categorize, document, and escalate observations, support investigations/CAPAs, assist trending and training, review deviations, and collaborate with cross-functional teams to drive quality improvements and maintain gown qualification and aseptic behaviors.

Lead QA oversight for aseptic processing areas, including sterility assurance and video monitoring staff. Manage media fills, environmental and personnel monitoring, airflow visualization, risk assessments, deviations/CAPAs, change control, and cGMP compliance. Provide training, competency qualification, quality metrics, cross-functional collaboration, regulatory inspection support, and people management for aseptic manufacturing quality.

Responsible for managing the change control lifecycle for pharmaceutical manufacturing changes, ensuring cGMP and SOP compliance. Reviews and approves change controls, coordinates with stakeholders, supports EDMS users, prepares metrics and product reviews, develops SOPs and training, and provides inspection and post-implementation support.