Senior Specialist – Complex Investigations

HOW MIGHT YOU DEFY IMAGINATION? 

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.  

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. 

Senior Specialist – Complex Investigations 

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What you will do 

Let's do this. Let's change the world. In this vital role, you will serve as the site expert responsible for leading the most critical, high-risk, and complex investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will partner with Manufacturing, Quality, Process Development, Engineering, Automation, Microbiology, and site leadership to investigate significant quality events, recurring deviations, product-impacting events, and systemic compliance issues. 
 
This position is responsible for ensuring the site's most consequential investigations are conducted with scientific rigor, thorough root cause determination, effective corrective and preventive actions, and clear communication to senior leadership. The role serves as the escalation point for investigations that present elevated product quality, patient safety, compliance, or regulatory risk. 

Responsibilities include: 

• Lead the site's most complex and cross-functional deviation investigations. 

• Serves as a technical resource for investigations involving complex quality, microbiology, manufacturing, or compliance issues. 

• Assembles and leads cross-functional investigation teams through advanced root cause analysis and risk assessment activities. 

• Apply advanced investigation methodologies including Kepner-Tregoe, Quality Risk Management, 5-Why, Fishbone Analysis, and data-driven problem solving. 

• Drive development of robust CAPAs and evaluate the effectiveness of implemented actions. 

• Identify systemic opportunities and recurring trends across quality events and drive site-wide improvement initiatives. 

• Provide expert technical guidance and coaching to investigators and functional SMEs.