QA Deviation Specialist

Job Description

Job Title: Deviations Investigator

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Location: Round Lake, IL (Onsite)

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Duration: 06+ months

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You will be responsible for:

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• Lead Minor, Major, and Critical Deviation investigations within assigned areas, ensuring thorough documentation and compliance with established quality procedures.

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• Collect, review, and analyze relevant raw data, records, and supporting information to facilitate comprehensive investigations.

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• 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.

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• Perform deviation trending and data analysis to identify adverse trends, recurring issues, and opportunities for corrective action.

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• Prepare, review, and finalize comprehensive investigation reports, ensuring accuracy, quality, and completion within established timelines.

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• Develop and implement effective Corrective and Preventive Actions (CAPAs), including follow-up mechanisms to verify implementation and long-term effectiveness.

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• Manage client communications, provide regular project progress updates, and report performance metrics to Project Leadership while ensuring timely approval and closure of investigation reports.

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About you:

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• Bachelor's degree from an accredited college or university.

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• 10+ years of experience working in Aseptic Processing facilities, with demonstrated expertise in manufacturing deviation investigations and technical report writing.

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• Expert-level understanding of deviation management, manufacturing process investigations, Root Cause Analysis, and CAPA development and execution.

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• Previous experience supporting or executing remediation plans in response to US FDA observations or regulatory requirements.

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• Extensive Quality Assurance experience across multiple areas, including PQR, auditing, change control, complaints management, OOS investigations, batch record review, and documentation management.

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• Experience with training programs, supplier quality management, and broader pharmaceutical quality systems within regulated manufacturing environments.

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