Senior Quality Assurance Associate II

Role: Quality Assurance professional overseeing cGMP compliance and vendor interactions in biopharmaceutical manufacturing. Responsibilities: manage CMO activities, review batch documentation, deviations, investigations, and change controls; ensure adherence to quality systems and international regulations; lead investigations into variances; support product development and release processes for API, drug substance, and drug product; monitor quality indicators and promote GMP standards; provide guidance and mentorship within QA teams and cross-functionally. Requirements: Bachelor's degree in a scientific discipline; 6+ years in pharmaceutical quality roles with thorough knowledge of FDA and EU cGMPs; experience in manufacturing, API, drug release, validation, and process transfer; strong troubleshooting, risk assessment, and organizational skills. High-Value: experience in pharmaceutical development, manufacturing operations, early-phase clinical trials, and regulatory documentation review. WorkSetup: Not specified.