QA Specialist II

Role: Quality Assurance specialist supporting GMP oversight of clinical small molecule drug substance and oral solid dosage manufacturing, focusing on product disposition and documentation review. Responsibilities: review and approve batch records, deviations, investigations, change controls, and GMP documentation; maintain accurate quality records; support daily QA operations including lot disposition and process improvements; participate in audits and inspections; execute root cause analyses and trend data. Requirements: BS with 4+ years (or MS with 2+ years) in a GMP-related field; strong knowledge of cGMPs, FDA/EMEA standards, and QA systems; proficiency in risk-based approaches, investigations, and document revision; excellent communication skills; experience in pharmaceutical manufacturing preferred. HighValue: GMP oversight of small molecule drug substance and OSD, clinical phase (implied by focus on product disposition and investigations), regulatory inspection support, quality systems, and risk management. WorkSetup: not specified; likely on-site or hybrid based on manufacturing oversight needs.