Specialist III, Quality Assurance

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. #J-18808-Ljbffr Scorpion Therapeutics