Senior CAPA Specialist - Minneapolis, MN
Core
Lead Corrective and Preventive Action (CAPA) activities and maintain quality system compliance for pharmaceutical manufacturing facilities.
Role type
Senior Quality Specialist (CAPA)
Builds
Quality system records, corrective action plans, and audit readiness documentation for patient safety.
Domain
Pharmaceutical manufacturing / Quality Management Systems
Required skills
CAPA process management, root cause analysis, regulatory compliance, quality system documentation, cross-functional collaboration, audit support, metrics analysis, team mentorship
Preferred skills
TrackWise proficiency, pharmaceutical/biotech experience, project leadership, continuous improvement initiatives
Responsibilities
Lead CAPA activities from initiation through effectiveness verification and closure; Review investigations and corrective action plans for compliance; Partner with manufacturing teams to drive process improvements; Monitor CAPA metrics and trends; Support internal audits and regulatory inspections; Prepare and maintain quality records and reports.
Seniority
Senior, hands-on IC
