Job Description

Quality Assurance CAPA Specialist

Department: Quality Assurance

Employment Type: Full Time

Location: Summerville, SC

RESPONSIBILITIES

• Lead and coordinate the CAPA process from initiation through implementation, effectiveness verification, and closure, ensuring alignment with Thorne procedures, cGMP requirements, and regulatory expectations.
• Serve as a CAPA subject matter expert, providing guidance to internal teams and external partners on investigations, root cause analysis, corrective actions, documentation, and CAPA best practices.
• Ensure appropriate CAPAs are initiated from quality events such as deviations, investigations, audits, complaints, OOS results, supplier issues, and OCM events.
• Lead and support structured root cause analysis, helping teams move beyond surface-level findings to identify the true causes of quality issues and develop sustainable solutions.
• Facilitate CAPA meetings and cross-functional discussions, ensuring actions are clear, risk-based, technically sound, and aligned with identified root causes.
• Review CAPAs for quality and effectiveness, including investigation findings, corrective and preventive actions, supporting documentation, effectiveness checks, and closure rationale.
• Manage and coordinate external CAPAs with OCMs and suppliers, reviewing responses for completeness and effectiveness and escalating late, ineffective, or high-risk issues when appropriate.
• Partner closely with Manufacturing, QC, Engineering, QA, Supplier Qualification, Planning, Procurement, and external partners to keep CAPAs moving forward and drive accountability for commitments and timelines.
• Maintain complete, accurate, traceable, and audit-ready CAPA records within Thorne’s Quality Management System.
• Track CAPA performance and trends through metrics, dashboards, and management reporting, using insights to identify risks and opportunities for improvement.
• Serve as a CAPA resource during internal audits, third-party audits, and regulatory inspections, providing documentation and subject matter expertise as needed.
• Identify opportunities to continuously improve CAPA workflows, tools, templates, and processes, and provide guidance or training to internal teams and external partners.
• Participate in internal audits, process improvement initiatives, and quality reviews for new products and processes.
• Maintain strong working knowledge of applicable SOPs, cGMPs, FDA requirements, and evolving industry expectations for CAPA and quality systems.
• Serve as a strong quality advocate, using sound judgment and constructive challenge when an investigation or proposed action does not adequately address product quality or prevent recurrence.
• Support Thorne’s commitment to quality, compliance, and safety, including taking appropriate action when product quality may be at risk.

WHAT YOU NEED

• Bachelor’s degree required in a scientific, engineering, or quality-related discipline; or equivalent combination of education and experience.
• 5+ years of quality experience, with at least 3 years of direct experience supporting or managing CAPA activities.
• Experience supporting or overseeing CAPAs for OCMs and/or suppliers.
• Demonstrated experience in project management or complex cross-functional initiatives.

WHAT WE OFFER

• Competitive compensation
• 100% company-paid medical, dental, and vision insurance coverage for employees
• Company-paid short- and long-term disability insurance
• Company- paid life insurance
• 401k plan with employer matching contributions up to 4%
• Gym membership reimbursement
• Monthly allowance of Thorne supplements
• Paid time off, volunteer time off and holiday leave
• Training, professional development, and career growth opportunities