Amgen

Overview

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.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Requirements & Eligibility

• Strong leadership capabilities
• Solid understanding of GMP, quality systems and inspection operations
• 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.