Senior Associate - Manufacturing Inspection

Position Overview

Join Amgen’s Operations team as a Senior Associate in Manufacturing Inspection, based in Dublin, Ireland. You'll play a vital leadership role, overseeing a dedicated group of Inspection Manufacturing Technicians in a dynamic and highly regulated drug product manufacturing environment.

Key Responsibilities

• Assist the Manufacturing Manager by leading a shift team of Inspection Manufacturing Technicians to meet production targets safely and within GMP, quality, and regulatory standards.
• Provide clear leadership, setting daily priorities to ensure manual and automated drug product inspection tasks align with production schedules and approved procedures.
• Manage inspection activities, guaranteeing adherence to Standard Operating Procedures (SOPs), batch records, inspection requirements, and cGMP guidelines.
• Lead a designated process area Work Centre Team (WCT) to align cross-functional priorities, address issues, and implement action plans effectively.
• Maintain intimate knowledge of manufacturing schedules and inspection statuses, proactively resolving constraints and coordinating critical tasks to fulfill production goals.
• Promote a robust culture of safety and quality, demonstrating leadership and upholding high standards within the inspection area.
• Ensure all Inspection Manufacturing Technicians remain properly trained, qualified, and certified; identify and address ongoing training or cross-training needs promptly.
• Oversee timely and precise completion and review of manufacturing documentation, including batch records and electronic batch records (EBRs), following Good Documentation Practices.
• Lead efforts to troubleshoot, escalate, and resolve inspection-related issues concerning processes, products, equipment, and quality to minimize manufacturing disruptions.
• Coordinate deviation and investigation activities in collaboration with Quality, Engineering, Maintenance, and support teams, driving resolutions efficiently.
• Monitor team and area performance and champion continuous improvement initiatives focusing on safety, quality, compliance, efficiency, and operational excellence using Lean principles and structured problem-solving methodologies.
• Ensure the inspection workspace is maintained in operational readiness for internal and external audits, including HPRA, FDA, and corporate inspections.
• Foster an inclusive, collaborative, and high-performing team atmosphere through effective communication, coaching, feedback, and professional development of technicians.
• Provide leadership and operational continuity during the Manufacturing Manager’s absence, managing escalations appropriately.

Employee Benefits and Work Environment

Amgen offers a comprehensive Total Rewards Plan designed to support overall health, financial wellness, work-life balance, and career progression. This includes extensive health and welfare benefits for employees and eligible dependents, a retirement savings plan with substantial company contributions, group medical, life and disability insurance, and a discretionary annual bonus program. Employees are empowered with exceptional learning, development, and career advancement opportunities within a supportive and growth-focused environment. Amgen is proud to be an equal opportunity employer committed to nurturing talent and fostering meaningful professional pathways.