2 builder jobs found

Nephron Pharmaceuticals Description:    Job Summary The BFS Line Technician I plays’ a vital role in ensuring the efficient and compliant operation of Blow-Fill-Seal machinery used in the production of sterile pharmaceutical products. This position is responsible for operating, monitoring, and maintaining BFS downstream equipment, ensuring product quality, and adhering to all Current Good Manufacturing Practices (CGMP), safety regulations, and company protocols. Key Responsibilities Equipment Operation Set up and operate BFS      downstream machinery according to established SOPs and Batch Records. Monitor machine performance      and production output to ensure efficiency and compliance. Perform routine adjustments      and troubleshoot minor issues to maintain continuous operation. Reset equipment alarms and      ensure all materials are properly staged for production. Quality Assurance & Documentation Accurately complete Batch      Records, logbooks,...

Nephron Pharmaceuticals Description:    Job Purpose: Provide strategic and operational leadership for Quality Operations supporting aseptic manufacturing, including Blow-Fill-Seal (BFS) and conventional sterile filling processes. Ensure full compliance with FDA 503B regulations, cGMP requirements, and applicable regulatory standards by establishing, maintaining, and continuously improving robust Quality Systems. Oversee quality oversight of facilities, utilities, equipment, and environmental monitoring programs to ensure sterility assurance and a sustained state of control. Lead and develop a high-performing Quality Operations organization, fostering a strong culture of quality, data integrity, inspection readiness, and continuous improvement. Partner cross-functionally with Manufacturing, Engineering, and Supply Chain to enable compliant, efficient operations, ensure uninterrupted supply, and serve as the primary Quality representative during regulatory inspections and...