About this role
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers . If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post. Sr Associate Manufacturing Deviation Owner Environmental & Contamination Control What you will do Let’s do this. Let’s change the world. 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 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 shopfloor 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 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 as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.