Specialist QA II Manufacturing Oversight

Role: QA Specialist II in Manufacturing Oversight at ADMA Biologics, focusing on compliance and quality assurance activities in biologics manufacturing. Responsibilities: perform real-time batch record review, oversee manufacturing documentation, review deviations, CAPAs, change controls, and OOS reports, conduct inspections of production areas, review and release plasma pools and raw materials, and ensure adherence to cGMP and FDA regulations (21 CFR Parts 11, 210, 211, 600). Collaborate with departments to assess deviations and support SOP development, training, and audits. Requirements: Bachelor's degree preferred or equivalent experience; 3-5 years in biotech/pharma manufacturing quality assurance; strong understanding of quality systems and regulatory compliance. Preferred skills include experience with LIMS and SAP. High-Value: biologics manufacturing, cGMP compliance, FDA regulations, plasma products, quality oversight, real-time batch review, SOP management. Work Setup: onsite in Boca Raton, FL, with emphasis on manufacturing floor oversight and documentation review, requiring strong organizational and communication skills.