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.

• - 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).

• - EDMS experience.
• - ERP experience.
• - ICH Q3, Q8, Q9, Q10, Q11.
• - Adobe Acrobat, Microsoft Office, Smart Sheet.
• - Strong communication and organization; ability to work independently in a fast-paced environment.

• - Wisconsin pay range: $85,000 USD - $95,000 USD.
• - Authorization to work in the country where the role is located is required.