QA Deviation Specialist

Job Title: Deviations Investigator Location: Round Lake, IL (Onsite)Duration: 06+ monthsYou will be responsible for:Lead Minor, Major, and Critical Deviation investigations within assigned areas, ensuring thorough documentation and compliance with established quality procedures.Collect, review, and analyze relevant raw data, records, and supporting information to facilitate comprehensive investigations.Lead Root Cause Analysis (RCA) activities to identify probable root causes, assess potential product impact, and establish appropriate CAPAs with assigned owners and due dates.Perform deviation trending and data analysis to identify adverse trends, recurring issues, and opportunities for corrective action.Prepare, review, and finalize comprehensive investigation reports, ensuring accuracy, quality, and completion within established timelines.Develop and implement effective Corrective and Preventive Actions (CAPAs), including follow-up mechanisms to verify implementation and long-term effectiveness.Manage client communications, provide regular project progress updates, and report performance metrics to Project Leadership while ensuring timely approval and closure of investigation reports.About you:Bachelor's degree from an accredited college or university.10+ years of experience working in Aseptic Processing facilities, with demonstrated expertise in manufacturing deviation investigations and technical report writing.Expert-level understanding of deviation management, manufacturing process investigations, Root Cause Analysis, and CAPA development and execution.Previous experience supporting or executing remediation plans in response to US FDA observations or regulatory requirements.Extensive Quality Assurance experience across multiple areas, including PQR, auditing, change control, complaints management, OOS investigations, batch record review, and documentation management.Experience with training programs, supplier quality management, and broader pharmaceutical quality systems within regulated manufacturing environments.