Quality Assurance CAPA Specialist
Thorne
full-time
Posted on:
Location Type: Office
Location: Summerville • South Carolina • United States
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About the role
- Coordinates and governs Thorne’s CAPA process, ensuring compliance with internal procedures, cGMP requirements, and regulatory expectations
- Serves as the primary point of contact for CAPA process questions, execution guidance, and continuous improvement
- Ensures CAPAs are appropriately initiated from deviations, investigations, audits, complaints, OOS, supplier issues, and OCM quality events
- Coordinates CAPA meetings and reviews, and ensures actions are clearly defined, risk-based, and capable of preventing recurrence
- Leads and supports structured root cause analysis using appropriate methodologies and challenges inadequate or superficial investigations and drives deeper root cause identification when needed
- Reviews corrective and preventive actions for technical adequacy and alignment to root cause
- Verifies CAPA effectiveness and ensures appropriate documentation and justification for closure
- Coordinates CAPA implementation, progress, and closure for Outside Contract Manufacturers (OCMs) and external suppliers
- Reviews supplier and OCM CAPA responses for completeness, technical soundness, and effectiveness
- Partners with Supplier Qualification, Procurement, and QA leadership to escalate late, ineffective, or high-risk external CAPAs
- Supports supply chain governance by ensuring external CAPAs are timely, risk-based, and audit-defensible
- Builds strong working relationships with Manufacturing, QC, Engineering, QA, Planning, Procurement, and external partners
- Facilitates cross-functional CAPA discussions and drives accountability for assigned actions
- Provides clear and professional communication with internal teams, OCMs, and suppliers regarding CAPA expectations and status
- Acts as a quality advocate by challenging weak responses while maintaining productive working relationships
- Ensures CAPA records are complete, accurate, traceable, and audit ready within the Quality Management System
- Compiles and maintains CAPA metrics, dashboards, and periodic reports for management review
- Supports internal audits, third-party audits, and regulatory inspections by providing CAPA documentation and serving as CAPA SME
- Proactively identifies opportunities to improve CAPA workflows, templates, and tools
Requirements
- Bachelor’s degree required in a scientific, engineering, or quality-related discipline; or equivalent combination of education and experience
- 7+ years of experience in a cGMP-regulated manufacturing environment with direct involvement in CAPA execution and quality systems
- Experience supporting or overseeing CAPAs for OCMs and/or suppliers strongly preferred
- Demonstrated experience in project management or complex cross-functional initiatives preferred
- Must be able to safely work with ingredients and products that are derived from possible allergenic sources
- Must be able to stay overnight when traveling for work and have the ability to travel 50% of the time
- Works independently with little direction or oversight, in a fast-paced environment
- Schedules projects and meets tight deadlines
- Develops and delivers on assigned objectives within requested timeframes
- Possesses good interpersonal skills and engages others in a positive manner
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CAPA processroot cause analysiscGMP compliancequality management systemproject managementcorrective actionspreventive actionsrisk assessmentaudit readinessmetrics compilation
Soft Skills
communicationinterpersonal skillscross-functional collaborationaccountabilityindependent worktime managementproblem-solvingrelationship buildingleadershipcontinuous improvement