Inspection Senior Associate

Senior Associate Manufacturing- Inspection

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What you will do

Let’s do this. Let’s change the world. As part of Amgen’s Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.

The Senior Associate reports to the Inspection Manager Manufacturing and will provide day-to-day leadership and oversight to a team of Inspection Manufacturing Technicians operating within a fast-paced, highly regulated Drug Product manufacturing environment.

The ideal candidate will have strong leadership capabilities together with a solid understanding of GMP, quality systems and inspection operations. They will provide clear direction, coaching and support to the Inspection Manufacturing Technicians to ensure inspection activities are executed safely, compliantly and in accordance with the production schedule. The successful candidate will foster a strong culture of safety, quality and continuous improvement and will have excellent troubleshooting and problem-solving skills.

Successful candidates will be required to work a shift pattern.

Key Responsibilities:

• Support the Manufacturing Manager in leading a shift team of Inspection Manufacturing Technicians to safely and efficiently achieve production targets in accordance with GMP, quality and regulatory requirements.
• Provide clear direction and daily priorities to Inspection Manufacturing Technicians to ensure manual and/or automated Drug Product inspection activities are executed in accordance with the production schedule and approved procedures.
• Provide day-to-day oversight of inspection operations, ensuring activities are performed in accordance with Standard Operating Procedures (SOPs), batch records, established inspection requirements and cGMP.
• Lead an assigned process area Work Centre Team (WCT), ensuring effective cross-functional alignment on operational priorities, issues and action plans.
• Maintain an accurate understanding of the manufacturing schedule and inspection area status, proactively identifying constraints and coordinating critical activities required to meet production targets.
• Foster a strong safety and quality culture within the shift team, acting as a role model and ensuring appropriate standards are consistently maintained within the inspection area.
• Ensure Inspection Manufacturing Technicians maintain the required training, qualifications and certifications to perform assigned inspection activities and proactively identify and address training or cross-training needs.
• Oversee the timely and accurate completion and review of manufacturing documentation, including batch records and electronic batch records (EBRs), in accordance with Good Documentation Practices and applicable procedures.
• Provide leadership and support in the identification, escalation and resolution of inspection-related process, product, equipment and quality issues to minimise disruption to manufacturing operations.
• Support and coordinate troubleshooting, deviation and investigation activities, working cross-functionally with Quality, Engineering, Maintenance and other support functions to drive issues to resolution.
• Monitor team and area performance and support the implementation of continuous improvement initiatives focused on safety, quality, compliance, efficiency and operational performance using Lean principles and structured problem-solving methodologies.
• Ensure the inspection area is maintained in a state of operational and inspection readiness and support internal, corporate, HPRA, FDA and other regulatory inspections as required.
• Build an inclusive, collaborative and high-performing team environment through effective communication, coaching, feedback and development of Inspection Manufacturing Technicians.
• Provide leadership for the shift team in the absence of the Manufacturing Manager, ensuring appropriate escalation and continuity of manufacturing operations.

Thrive

What you can expect of us

In addition to the base salary, Amgen offers a Total Rewards Plan designed to support your health, financial wellbeing, work/life balance, and long-term career growth. Comprehensive employee benefits package, including health and welfare plans for staff and eligible dependents, retirement and savings plan with generous company contributions, group medical, life and disability insurance. Discretionary annual bonus program. Exceptional learning, development, and career advancement opportunities, empowering employees to grow and build long-term careers. At Amgen, we are committed to nurturing talent and providing meaningful pathways for professional development.

Amgen is an equal opportunity employer.