Specialist Manufacturing Deviation Owner - West Greenwich, RI

Job Description 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. What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible 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 Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready. Critical thinker who is able to structure investigational workflows with cross‑functional team members that help drive teams to sound, data‑driven conclusions that 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 Provides mentorship/coaching to more junior deviation owners 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 Drive 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 primary 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 Supports continued analysis and improvement of deviation processes. Support Deviation trending Data analysis for recurring issues Identify and help to implement 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. Minimum Education Required High School/GED Job Category Manufacturing Additional Qualifications/Responsibilities Basic Qualifications High school diploma/GED and 10 years of directly related experience OR Associates degree and 8 years of directly related experience OR Bachelor’s degree and 4 years of directly related experience OR Master’s degree and 2 years of directly related experience OR Doctorate degree Preferred Qualifications BS/BA or equivalent (science/engineering/psychology preferred) 8+ years of experience in the pharmaceutical industry Experience applying AI or other digital tools to generate insights and streamline workflows Salary Range

107,545.40 USD - 145,502.60 USD