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. Deviation Ownership & Execution Demonstrated technical writer able to articulate complex events into concise and clear documentation that is inspection ready. Advanced thinker who, with some oversight from management and mentors, is able to structure investigational workflows with cross‑functional team members that help drive teams to sound, data‑driven conclusions and advance deviation records forward. Serve as the designated owner for deviation records (initial job scope may focus on Environmental and Contamination Control; however, scope can be 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 shop‑floor observations and Gemba activities, including 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 various organizations across the site and network including the Contamination Control Lead, Contamination Control Network, process specialists, Quality Assurance (QA), QC/microbial experts, Process Development, and Facilities and 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 and 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. All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities. 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. Preferred Qualifications The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of 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 A 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. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications. 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 BioSpace, Inc.