Specialist III, Quality Assurance (Raw Material Qualification)

Location: Madison, Wisconsin, United States

Company

Consulting organization partnering with pharmaceutical and biotech companies on regulated quality and manufacturing programs.

What you will do

• Support raw material lifecycle management, including specifications, qualification protocols, reports, and requalification cycles.
• Conduct material risk assessments focused on product quality, patient safety, and regulatory compliance.
• Support supplier qualification, audits, requalification, change notifications, and supplier performance monitoring.
• Manage the Approved Supplier List, supplier corrective action requests, material-related change controls, deviations, CAPAs, and root cause analysis.
• Review supplier documentation, maintain quality records in eQMS and EDMS, and prepare procedural documentation.
• Track, trend, and analyze raw material quality metrics while providing quality oversight during material onboarding and lifecycle management.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific field preferred.
• 5+ years of Quality Assurance experience in a GMP-regulated biotech or pharmaceutical environment.
• Strong experience with raw material release, supplier quality, and/or material qualification.
• Working knowledge of 21 CFR Parts 210/211, ICH Q7, and FDA, EMA, and Health Canada regulatory expectations.
• Experience with EDMS and ERP systems in regulated environments preferred.
• Strong communication, organizational, prioritization, and independent working skills.

Nice to have

• Familiarity with ICH Q3, Q8, Q9, Q10, and Q11.
• Proficiency with Adobe Acrobat, Microsoft Office, and SmartSheet.

Culture & Benefits

• Work within a GMP-regulated pharmaceutical manufacturing environment.
• Collaborate with suppliers, Supplier Quality Audits, and external partners.
• Follow established procedures, policies, and work instructions while managing multiple priorities.