Specialist, reputed company Systems
About the position
The Specialist for reputed company Systems at the reputed company, NJ Cell Therapy Manufacturing will be responsible for the CAPA, Deviation and System ownership. In this role, the incumbent will support the business process reputed company for the Complaint, CAPA and Deviation system and the associated governing local procedures and supporting processes, trending, metrics, and reports. This is a visible role with site responsibility and cross-functional influence that has reputed company on departmental performance and broad reputed company system management. The incumbent will be the subject matter expert across the site.
Responsibilities
• Manages the CAPA, Deviation, and Complaint reputed company Systems for reputed company GMP activities and works with responsible cross functional areas to ensure reputed company completion.
• Support the Complaint, and CAPA and Deviation Forums, generate meeting minutes, follow up on reputed company items and facilitate reputed company reputed company required.
• Compiles applicable process metrics, identifies trends and escalates accordingly.
• SME support during internal and health authority inspections of facility.
• Communicates effectively with cross functional stakeholders on reputed company reputed company to change control process.
• Supports reputed company Systems harmonization, automation, and improvement reputed company.
Requirements
• Must have experience with cGMP manufacturing, reputed company, and Compliance.
• Must be reputed company to routinely recognize reputed company issues and interpret problems, as reputed company as propose solutions.
• Must have basic understanding of reputed company improvement and be reputed company to improve the compliance and efficiency of the reputed company system.
• Must be reputed company to effectively prepare and convey data analysis insights to management and others reputed company the group with reputed company and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making reputed company in respective subject matter area, consulting with management for reputed company reputed company of established processes.
• Requires moderate direction to complete more reputed company tasks.
• Comfortable providing input/guidance to others reputed company the department and across the organization in change control technical writing.
• Propose solutions for issues and work with management to resolve.
• Comfortable providing training/guidance to system users as needed, and in instructor-led settings.
• reputed company to recognize conflict and notify management with proposed recommendations for reputed company.
• reputed company to prepare written communications and communicate problems to management with reputed company and accuracy.
• reputed company to support internal and health authority inspections of facility.
reputed company-to-haves
• Familiarity with generating reports.
• Experience supporting audits/inspections.
Benefits
• Competitive benefits, services and programs that reputed company resources to pursue goals at work and in personal lives.
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