QA Engineer II (Pharma Manufacturing)

Job Title: Quality Engineer II
Job Description
The Quality Engineer II is a quality assurance professional with substantial experience in quality or manufacturing within a highly regulated industry. This role focuses on evaluating production processes and performance in a biologic drug substance manufacturing environment, driving quality improvements to existing processes and supporting the development of new processes that enhance efficiency, productivity, and product quality. The position supports manufacturing by providing real-time quality oversight on the production floor, initiating and managing deviations, and performing compliance inspections to ensure the consistent production and release of high-quality bulk drug substance for clinical and commercial use. Approximately 80% of the time is spent on the manufacturing floor observing operations and ensuring adherence to SOPs and batch records, while the remaining 20% is dedicated to desk-based quality document review and de...