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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Manufacturing Specialist Investigator

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will conduct technical investigations from our clinical and commercial drug Substance Operations. Responsible for understanding the investigation process as well as manufacturing processes for the Amgen Rhode Island Facility. The Manufacturing Specialist Investigator owns major and trend deviations to support identifying root cause and will also participate in multi-functional conceptualization of design solutions (CAPAs). Maintains close interaction with the Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate product impact and supply to product/process improvement.

• Lead root cause analysis to identify the failure mode.
• Identify root cause using tools such as fishbone diagrams, “5 Whys”, KT, Process mapping, and risk assessments such as FMEA’s or Fault Tree Analysis.
• Applies knowledge and subject matter expertise to ensure end-to-end of investigations
• Lead discussion to reduce, correct, mitigate and prevent the reoccurrence of the event based on output of root cause analysis.
• Perform trend investigations, including statistical assessment of data to identify trends, as well as generation of reports.
• Generate final technical reports, which may include data collection and statistical analysis of the data
• Perform notification of potential product impact.
• Advise management on investigation progress, product/ process risk, and potential delays.
• Support functional management initiatives and objectives
• Anticipates and prevents potential issues with regulators
• Own and/or Drive Improvement projects/initiatives
• Collaborate cross functionally as needed to ensure the Quality Management System processes are completed in accordance with established procedures.
• Alert senior management of quality, compliance, supply and safety risks.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing Specialist Investigator we seek is an excellent communicator with these qualifications:

Basic Qualifications:

Doctorate degree OR

Master’s degree and 3 years of Manufacturing or Operations experience Or

Bachelor’s degree and 5 years of Manufacturing or Operations experience Or

Associate’s degree and 10 years of Manufacturing or Operations experience Or

High school diploma / GED and 12 years of Manufacturing or Operations experience

Preferred Qualifications:

• 5+ years of proven ability in investigation process.
• Strong technical writing
• Proven Six Sigma proficiency specifically for root cause analysis methodology
• Understanding and application of Drug Substance process, data mining, quality and compliance.
• Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
• Project Management experience
• Able to influence tri-functional team and interpersonal leads

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, improve your expertise, and enhance your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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