Quality Operations Manager

Job description

Overview Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211. This position works closely with the Quality Managers and the Production Department to ensure Quality Assurance compliance with regulatory and customer requirements. This position works with all supervision and employees to ensure that cGMPs and Praxis SOPs, policies and work instructions are being followed. Responsibilities: Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed. - Ensures the content and executional effectiveness of the QA Programs. - Responsible to ensure products meet qualityand efficiency standards set by the company. - Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories. - Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures. - Maintains and improves product quality by compl...