Senior Specialist – Complex Investigations

Amgen•Holly Springs, NC

10d•Onsite

About The Position

Amgen is seeking a Senior Specialist – Complex Investigations for its newest and most advanced drug substance manufacturing plant, the Amgen FleX batch facility. This facility combines cutting-edge single-use and traditional stainless steel technologies with industry 4.0 capabilities and sustainability innovations. The Senior Specialist will be the site expert responsible for leading critical, high-risk, and complex investigations within the Biologics Drug Substance Manufacturing plant. This role involves partnering with various departments to investigate significant quality events, deviations, and compliance issues, ensuring scientific rigor, thorough root cause determination, and effective CAPAs. The position serves as an escalation point for investigations with elevated risks to product quality, patient safety, and regulatory compliance.

Requirements

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

Nice To Haves

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.

Responsibilities

Lead the site's most complex and cross-functional deviation investigations.
Serve as a technical resource for investigations involving complex quality, microbiology, manufacturing, or compliance issues.
Assemble and lead 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 investigation 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.