QA Deviation Specialist

Job description

The QA Deviation Specialist is responsible for identifying, documenting, investigating, and resolving deviations, unplanned events, complaint investigations in accordance with company SOPs, policies, cGMPs, protocols, or regulatory requirements. This is a cross-functional position that interacts with all departments at Lonza Tampa. The role is responsible for authoring, reviewing, and/or providing the final Quality approval for investigations into manufacturing, packaging and/or laboratory events/deviations. Key Accountabilities: Facilitate and lead assigned investigations involving multiple investigation areas. Work with various departments, including manufacturing, packaging, quality control, maintenance, engineering, and supply chain, to conduct investigations, determine root cause and implement improvements. Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause. Analyze deviation trends and provide insights for continuous improvement initiatives. Ensure that investigations and reports are completed and closed within specified timelines. Assess deviation potential impact to product...