Manufacturing Quality & CAPA Principal Analyst

Scorpion Therapeutics; Libertyville (IL); On-site; USD 110,000 - 170,000; Full time

Job summary

Scorpion Therapeutics in Libertyville, IL is seeking a Manufacturing Investigation Principal Analyst to lead deviation investigations, ensure quality compliance, and drive CAPA across manufacturing operations.

You will collaborate with Manufacturing, Quality, Engineering, and Supply Chain; analyze trends, implement CAPAs, and mentor junior staff while maintaining inspection readiness.

Qualifications

• Bachelor’s degree required in life sciences or related field.
• Multiple years of GMP-regulated pharma/biotech manufacturing experience.
• Experience leading deviation investigations and CAPA management.
• Strong GMP and quality system knowledge.
• Experience with QMS and regulated investigation workflows.
• Excellent technical writing and stakeholder management skills.

Responsibilities

• Lead deviation investigations within the Quality Management System.
• Perform trend analysis on deviations and quality events to identify recurring issues.
• Drive root cause analysis and ensure effective CAPA implementation.
• Maintain and improve deviation investigation procedures and quality processes.
• Provide technical expertise on investigation methodologies and compliance requirements.
• Partner with stakeholders to ensure timely communication, escalation, and resolution of quality events.
• Support inspection readiness and responses to regulatory observations when required.
• Participate in continuous improvement; mentor junior colleagues.

Skills

Deviation investigations

CAPA management

Root cause analysis

GMP knowledge

Technical writing

Stakeholder management

Regulatory readiness

Education

Bachelor’s degree in Life Sciences, Biotechnology, Pharmacy, Engineering, or related scientific discipline

Tools

Quality Management System (QMS)

Regulated investigation workflows

Job description

Scorpion Therapeutics in Libertyville, IL is seeking a Manufacturing Investigation Principal Analyst to lead deviation investigations, ensure quality compliance, and drive CAPA across manufacturing operations.

You will collaborate with Manufacturing, Quality, Engineering, and Supply Chain; analyze trends, implement CAPAs, and mentor junior staff while maintaining inspection readiness.