Senior Specialist – Complex Investigations

About this role

Career Category Manufacturing Job Description 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  

Live  

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.  

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

• Assemble s   and lead s   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.  

• Present investigation status, findings, risks, and recommendations to site leadership and governance teams.  

• Support regulatory inspections and internal audits by presenting investigatio n strategies,   outcomes, and   associated remediation activities.  

• Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology organizations to ensure   timely   and compliant   investigation   closure.  

• Develop and   maintain   metrics that assess   investigation   quality, effectiveness, and timeliness.  

• Drive continuous improvement of investigation processes, tools, and standards across the site.  

• Author and review technically complex investigation reports, risk assessments, and executive summaries.  

• Mentor investigators on investigation excellence, technical writing, and root cause analysis.  

• Influence site-wide investigation practices through knowledge sharing, process optimization, and implementation of industry best practices.  

​

Win  

What we expect of you  

The collaborative investigator we   seek   has extensive experience leading complex investigations in a regulated biotechnology or pharmaceutical environment and   demonstrates   exceptional technical, analytical, and leadership capabilities.  

Basic Qualifications:  

Doctorate degree &   2   year of   directly related   experience     Or     Master's degree &   4  years of   directly related   experience     Or     Bachelor's degree &   6   years of   directly related   experience     Or     Associate's degree & 10 years of   directly related   experience     Or     High school diploma / GED & 12 years of   directly related   experience  

Preferred Qualifications:  

• 7 + years of biotechnology or pharmaceutical industry experience with progressively increasing responsibility.  

• Extensive experience leading complex, cross-functional investigations involving quality systems, manufacturing processes, microbiology, contamination control, or compliance-related issues.  

• Demonstrated   expertise   in advanced root cause analysis methodologies and quality risk management.  

• Strong understanding of GMP regulations, quality systems, deviation management, CAPA systems, and regulatory expectations.  

• Experience serving as a lead presenter or SME during regulatory inspections and internal audits.  

• Experience using Veeva QMS for investigations and CAPA management.  

• Demonstrated ability to influence cross-functional teams and senior leadership.  

• Strong project management and organizational skills.  

• Exceptional technical writing and verbal communication skills.  

• Degree in Science or Engineering (Microbiology, Biology, Chemical Engineering, Biochemistry, or related discipline preferred).  

• Ability to navigate ambiguity and provide structured, data-driven decision making.  

• Demonstrated ability to mentor investigators and influence investigation practices across multiple functional areas.  

Thrive  

What you can expect of us   

In additi

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