Senior Raw Materials QA Specialist

Scorpion Therapeutics; Verona (WI); On-site; USD 85,000 - 95,000; Full time

Job summary

Scorpion Therapeutics is hiring for a QA professional focused on raw materials. You will review specifications, support supplier qualification and change controls, and maintain eQMS records. A strong background in GMP biotech and regulatory expectations is required.

Responsibilities include risk assessments, SCAR handling, and collaboration with suppliers to resolve quality issues, ensuring fast, compliant material onboarding and lifecycle management.

Qualifications

• BS/BA in Chemistry, Biology, Biochemistry, or related field.
• 5+ years QA experience in GMP biotech/pharma.
• Working knowledge of 21 CFR 210/211, ICH Q7, and global regulatory expectations.

Responsibilities

• Support raw material lifecycle management and ensure compliance.
• Perform raw material risk assessments for quality and safety.
• Maintain ASL in the eQMS and input qualification data.
• Review Supplier Change Notifications and assess impact to quality.
• Assist with deviation investigations, CAPAs, and root cause analyses.

Skills

QA experience

GMP knowledge

Regulatory compliance

Education

BS/BA in Chemistry/Biology/Biochemistry

Tools

EDMS

ERP

Adobe Acrobat

Microsoft Office

SmartSheet

Job description

Scorpion Therapeutics is hiring for a QA professional focused on raw materials. You will review specifications, support supplier qualification and change controls, and maintain eQMS records. A strong background in GMP biotech and regulatory expectations is required.

Responsibilities include risk assessments, SCAR handling, and collaboration with suppliers to resolve quality issues, ensuring fast, compliant material onboarding and lifecycle management.