Senior Associate Manufacturing Deviation Owner Environmental and Contamination Control

Sr Associate Manufacturing Deviation Owner Environmental & Contamination Control In this vital role you will be accountable for end-to-end management of assigned deviation records, including investigation, documentation, and resolution, ensuring compliance with site procedures and regulatory expectations. Responsibilities Deviation Ownership & Execution Demonstrated technical writing skills to articulate complex events into concise, inspection‐ready documentation. Advanced thinker capable of structuring investigational workflows with cross‑functional team members to drive data‑driven conclusions and advance deviation records forward. Serve as the designated owner for deviation records (initial scope may focus on Environmental and Contamination Control but may expand across manufacturing events). Ensure timely progression and closure of deviations. Maintain accountability for data integrity and completeness of records. Investigation & Root Cause Analysis Define and execute investigation strategy. Conduct shopfloor observations, Gemba activities, and interviews. Develop, schedule, and execute root cause analyses (RCA) and ensure scientific justification of conclusions. CAPA Development & Effectiveness Lead CAPA identification and development aligned with investigation outcomes. Support CAPA and Effectiveness Verification (EV) management activities. Cross‑Functional Coordination Work with site and network organizations including Contamination Control Lead, Contamination Control Network, process specialists, Quality Assurance (QA), QC/microbial experts, Process Development, and Facilities & Engineering. Ensure appropriate functional input into investigations and decisions. Documentation & Decision‑Making Advance strategic decision‑making for deviation documentation updates. Ensure records meet QMS and SOP requirements. Support change control impact assessments where deviations trigger system/process changes. Regulatory & Inspection Interface Act as SME during inspections for assigned deviations. Be prepared to defend investigation rationale and classification decisions. Participate in daily updates / inspector engagements when required. Data Analysis & Continuous Improvement Provide inputs to: Deviation trending Data analysis for recurring issues Identify and share opportunities for prevention strategies and contamination control improvements. Leverage AI and digital tools compliantly to streamline investigation processes. Qualifications Basic Qualifications High school diploma/GED and 4 years of manufacturing and/or operations experience. Associate’s degree and 2 years of manufacturing and/or operations experience. Bachelor’s degree and 6 months of manufacturing and/or operations experience. Master’s degree or equivalent (educational experience may be considered). Preferred Qualifications Knowledge and skills typically acquired through education and experience or the equivalent; BS/BA or equivalent (science/engineering/psychology preferred). 2+ years of experience in the pharmaceutical industry. Experience applying AI or other digital tools to generate insights and streamline workflows. Benefits 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. Flexible work models where possible. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. 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. #J-18808-Ljbffr Amgen