Jnj - Winterville, GA
posted 4 months ago
The Specialist 3 - Operations position at Johnson & Johnson is a contract role focused on providing technical support for the manufacturing processes of Active Pharmaceutical Ingredients (API), medical device raw materials, or medical device components. This role is critical in ensuring compliance with all applicable procedures and regulations while addressing atypical events and nonconformance investigations. The Specialist will work under limited direction from operations management and is expected to monitor and trend key process parameters, troubleshoot manufacturing problems, and identify and implement process improvements. Additionally, the Specialist will support capital projects and site-wide initiatives, acting as a project lead or subject matter expert as needed. In this role, the Specialist will provide primary production support, plan and control production schedules, and facilitate the implementation of production plans. They will take corrective actions for daily operational problems and act as a subject matter expert, guiding investigations and quality issues. The Specialist will also study existing processes to identify areas for improvement, recommend corrective measures, and ensure that all actions taken address the root causes of nonconformance events. The position requires collaboration with Quality Assurance to maintain consistent quality standards and involves tracking deviations and key process parameters, providing management with reports on trends and statuses. The Specialist will also be responsible for ensuring regulatory compliance and technical feasibility of proposed changes, initiating and executing change controls for projects, and improving process data collection and analysis. The role emphasizes the importance of safety, environmental compliance, and productivity, and requires the Specialist to connect inclusively within the department and across the company to address customer needs. The Specialist will also engage in personal and professional development, manage documentation for SOP and batch record revisions, and assist with equipment startup and technical training. They will demonstrate expertise in cGMPs, FDA regulations, and manufacturing processes, and will be responsible for handling controlled substances in compliance with applicable laws.