Career CategoryManufacturing
Job DescriptionSenior 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.
- 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.
- 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.
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 addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us.
careers.amgen.com Salary Range137,263.10USD -185,708.90 USD
