Senior Specialist - Contamination Control and Investigations

Senior Specialist – Contamination Control and Investigations Amgen North Carolina Biologics Drug Substance Manufacturing Plant Responsibilities Manage complex contamination-related deviation investigations, including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events, and product quality investigations. Represent the site in the Contamination Control Network and collaborate with network partners to align contamination control strategies, standards, lessons learned, and best practices while driving implementation of network initiatives and continuous improvement opportunities. Provide technical leadership for contamination control-related audit and inspection responses, partnering with cross-functional teams to assess observations, develop risk-based remediation strategies, and ensure effective and sustainable corrective actions. Support development, implementation, maintenance, and continuous improvement of the site's contamination control strategy. Drive improvements to contamination control programs, contamination risk assessments, and investigation processes. Lead contamination control inspection readiness activities and serve as a contamination control SME during regulatory inspections, internal audits, and management reviews. Present contamination control strategies, investigation outcomes, and risk assessments to inspectors, auditors, and site leadership. Perform trend analysis of environmental monitoring, utilities, contamination-related deviations, and quality events to identify emerging risks. Coordinate and effectively lead cross-functional teams through complex contamination-related investigations and complete milestones on schedule. Identify systemic contamination risks and drive site-wide corrective and preventive actions. Partner with CCS network leads, QC Microbiology, Manufacturing, Engineering, Process Development, and Quality organizations to strengthen contamination prevention programs. Apply advanced root cause analysis methodologies and quality risk management principles. Navigates ambiguity and provides a structured, science-based problem-solving approach. Develop metrics and tracking tools to ensure on‑time closure of investigations and ongoing effectiveness of contamination control programs. Mentor investigators and operational personnel on contamination control principles, contamination risk management, and investigation excellence. Serve as a site SME for contamination control principles, contamination risk management, and contamination prevention strategies. Qualifications Basic Qualifications: Doctorate degree & 2years of directly related experience OR Master’s degree & 4years of directly related experience OR Bachelor’s degree & 6years of directly related experience OR Associate’s degree & 10years of directly related experience OR High school diploma / GED & 12years of directly related experience. Preferred Qualifications: 7+years related work experience (microbiology, sterility assurance, manufacturing, process development, engineering, or quality assurance) in the biotechnology or pharmaceutical industry with progressively increasing responsibility. Strong experience with contamination control programs, contamination risk management, investigations, quality systems, and compliance. Degree in Science or Engineering; microbiology studies or major a plus. Experience developing, implementing, or maintaining contamination control strategies and contamination risk management programs. Experience leading highly complex contamination-related investigations and performing contamination risk assessments to support quality and manufacturing operations. Knowledge of Annex1, FDA, EMA, and global GMP requirements related to contamination control and sterility assurance. Experience using Veeva QMS for deviation investigations and CAPAs. Experience presenting during regulatory inspections and internal audits. Experience assessing and responding to contamination control-related audit or inspection observations and driving sustainable corrective actions. Demonstrated project management ability. Strong knowledge of environmental monitoring, utility monitoring, aseptic processing, and contamination prevention principles. Excellent written and verbal communication skills. Ability to work in a matrix environment and build strong cross‑functional partnerships. Strong interpersonal and technical leadership skills. Benefits Comprehensive employee benefits package including health, dental, vision, life, and disability insurance and flexible spending accounts. Retirement and Savings Plan with generous company contributions. Flexible work models, including remote work arrangements where possible. Discretionary annual bonus program and stock‑based long‑term incentives. Time‑off plans and bi‑annual company‑wide shutdowns. 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 to participate in 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. Salary Range: 137,263.10USD – 185,708.90USD #J-18808-Ljbffr Amgen Inc. (IR)