Senior Specialist Complex Investigations Employer Amgen Location Holly Springs, North Carolina Start date Jul 15, 2026 View more categories View less categories Discipline Clinical , Clinical Medicine Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel likeyourepart of something bigger,itsbecause you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over10 million patientsworldwide.

Itstime for a career you can be proud of. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the AmgenFleXbatch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations TheFleXBatch 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'sdo this.

Let'schange 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 positionis responsible forensuring 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 complexand cross-functionaldeviation investigations. Servesasa technical resourcefor investigations involvingcomplexquality,microbiology,manufacturing, orcomplianceissues. Assemblesand leadscross-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. Drivedevelopmentof robust CAPAs andevaluate the effectivenessof implemented actions. Identifysystemicopportunitiesand 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, andassociated remediation activities. Partner with Quality, Manufacturing, Engineering, Process Development, and Microbiology organizations to ensuretimelyand compliantinvestigationclosure. Develop andmaintainmetrics that assessinvestigationquality, 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 weseekhas extensive experience leading complex investigations in a regulated biotechnology or pharmaceutical environment anddemonstratesexceptional technical, analytical, and leadership capabilities.

Basic Qualifications:

Doctorate degree &2year ofdirectly relatedexperience Or Master's degree &4years ofdirectly relatedexperience Or Bachelor's degree &6years ofdirectly relatedexperience Or Associate's degree & 10 years ofdirectly relatedexperience Or High school diploma / GED & 12 years ofdirectly relatedexperience

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. Demonstratedexpertisein 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 Plancomprisinghealth 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 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. #AmgenNorthCarolina Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.

Company info Website http:

//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Laboratory Operations Technician, Part-Time Waltham, Massachusetts Senior Manager, Congress Operations Washington D.C., District of Columbia Senior Administrative Assistant, International & State Government Affairs North Chicago, IL