QA Deviation Specialist

Job Title: Deviations Investigator

Location: Round Lake, IL (Onsite)

Duration: 06+ months

You 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.