Specialist III, Quality Assurance

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

Responsibilities:

• - Support raw material lifecycle management: draft/edit/review/approve raw material specifications; review qualification protocols/reports; ensure compliance with requalification cycles.


• - Perform raw material risk assessments (product quality, patient safety, regulatory compliance).


• - Support supplier qualification and requalification with the Supplier Quality Audits team.


• - Maintain the ASL by providing/entering qualification information into the eQMS.


• - Collaborate with suppliers to resolve quality issues, documentation discrepancies, and non-conformances.


• - Review Supplier Change Notifications and assess impact to product quality.


• - Initiate and manage raw-material change controls.


• - Manage Supplier Corrective Action Requests (SCARs).


• - Support deviation investigations, CAPAs, and root cause analyses involving material issues.


• - Provide quality oversight during material onboarding and lifecycle management.


• - Request/review qualification documentation (e.g., production records, CoA, CoC, BSE/TSE statements).


• - Scan/upload executed documents to the EDMS, categorize, and route for verification/approval.


• - Assist with preparation/update/review/routing of procedural documents.


• - Track and trend raw-material quality metrics.


• - Assist with other QA duties as needed.

Requirements:

• - BS/BA in Chemistry, Biology, Biochemistry, or related field (preferred).


• - 5+ years QA experience in GMP-regulated biotech/pharma, with emphasis on raw material release, Supplier Quality, and/or material qualification.


• - Working knowledge of 21 CFR 210/211, ICH Q7, and global regulatory expectations (e.g., FDA/EMA/Health Canada).

Preferred:

• - EDMS experience.


• - ERP experience.


• - ICH Q3, Q8, Q9, Q10, Q11.


• - Adobe Acrobat, Microsoft Office, SmartSheet.


• - Strong communication and organization; ability to work independently in a fast-paced environment.

Benefits/Application:

• - Wisconsin pay range: $85,000 USD - $95,000 USD.


• - Authorization to work in the country where the role is located is required.