Hiring: Senior Specialist – Complex Investigations Company: Amgen Location: Holly Springs, NC Job Posted Time: 2026-09-16 21:04:59 Employment Type: Remote Target Skills & Keywords : Embedded Systems, Project Management, Risk Management, Root Cause Analysis About the job Experience: •2 year of directly related experience •4 years of directly related experience •6 years of directly related experience •10 years of directly related experience •12 years of directly related experience Required Skills: •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. •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. Qualifications: •Doctorate degree & 2 year of directly related experience •Or 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 •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. •In-depth knowledge of GMP regulations, quality systems, deviation management, CAPA systems, and regulatory expectations. •Demonstrated ability to influence cross-functional teams and senior leadership. •Strong project management and organizational skills. Compensation: •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!