Specialist Manufacturing

What you will do

The External Supply (ES) Raw Material and Devices Quality Records (RMD QRO) global team supports the Amgen manufacturing network by managing supplier notifications and investigations related to raw material and device defects, onboarding new or alternate raw materials, suppliers, and sites, and managing life-cycle changes to existing materials or suppliers.

The External Supply Specialist Manufacturing owns and executes independently all processes related to Raw Material and Devices (RMD) quality records, including Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations (minor and major), Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications. This role acts as the External Supply QRO representative across functional teams and external suppliers to drive closure of quality records in a timely manner.

Responsibilities

• Own, manage, and close quality records (Supplier Event Notifications and Investigations (EN/SICAR), Change Controls, Deviations, Corrective and Preventive Actions (CAPAs), and CAPA-Effectiveness Verifications) under the company's quality management system procedures and ensure compliance with regulatory agency requirements.
• Facilitate cross-functional teams (internal and external to the site) to achieve robust and detailed investigation performance or timely implementation of supplier/raw material related changes.
• Partner cross-functionally across the network to ensure maturity and execution of robust quality record process.
• Lead investigation teams to identify meaningful root causes and robust corrective and preventative actions using advanced root cause analysis tools (Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.).
• Manage closure of multiple quality records simultaneously and in a timely manner (Deviations, Change Controls, ENs, SICARs, CAPA, CAPA-EV).
• Collaborate closely with External Supply Quality, ES SRE teams, Amgen sites, and suppliers to ensure robust supplier/raw material investigations, timely change implementation, and compliance with KPI metrics.
• Build and present quality record summaries for Senior Management review.
• Provide timely and comprehensive process and status updates to senior management in multiple forums and keep tracking tools updated.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is diligent with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master's degree and 2 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR
• Bachelor's degree and 4 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR
• Associate's degree and 8 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries OR
• High school diploma / GED and 10 years of Quality and/or Manufacturing experience in the pharmaceutical, biotech or medical device industries

Preferred Qualifications

• 3+ years related work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Experience managing quality records (EN/SICAR, Change Controls, Deviations, CAPAs, CAPA-EV) using TrackWise or Veeva System.
• Project Management skills and experience.
• Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Experience presenting to and interacting with representatives of regulatory agencies.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Demonstrated ability to lead continuous improvement opportunities and complex cross-functional initiatives that enhance processes, improve operational efficiency, and support timely, compliant execution across internal teams and Amgen sites.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook).
• Experience navigating and executing transactions in SAP (ERP) or S4HANA system.
• Experience applying AI-enabled tools in a regulated environment.
• Experience contributing to the design, development, or implementation of AI-enabled tools as part of process improvement initiatives or projects.
• Ability to translate business or quality process needs into practical solutions and evaluate outputs for accuracy, data integrity, and compliance with applicable requirements.
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Demonstrated ability to deliver results through living the Amgen values.
• Strong negotiation skills when working with external suppliers and internal team members.
• Ability to maintain remote working relationships with colleagues at other Amgen sites.