Teams at American Regent, Inc.

Lead and manage clinical quality assurance activities including study-specific audit planning and execution across Pharmacovigilance, Clinical Operations, Quantitative Sciences, and Regulatory Affairs. Evaluate regulatory compliance, generate audit reports, manage CAPAs, support inspection readiness, and drive continuous process improvement and SOP development. Provide training, onboarding, and independent regulatory compliance advice for human and animal clinical programs and post-marketing safety activities.

Lead manufacturing quality activities for aseptic pharmaceutical production: manage investigations and CAPAs, perform root cause analysis, write technical documents, support training and gown qualifications, ensure cGMP compliance, partner with manufacturing and cross-functional teams, and drive continuous improvement and environmental monitoring programs.

Entry-level Formulation/Manufacturing role executing compounding tasks under cGMP and SOPs. Duties include weighing bulk, cleaning equipment and filters, calibrating scales and pH meters, sampling, recording batch data with integrity, coordinating with supervisors and other departments, and maintaining cleanliness and safety in compounding areas.