Quality Assurance CAPA Specialist

Quality Assurance CAPA Specialist

Department: Quality Assurance

Employment Type: Full Time

Location: Summerville, SC

At Thorne, we work to deliver high‑quality, science‑backed solutions to empower individuals to take a proactive approach to their well‑being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.

The Quality Assurance (QA) CAPA Specialist is responsible and accountable for the execution, governance, and effectiveness of Thorne’s Corrective and Preventive Action (CAPA) program across internal manufacturing operations, Outside Contract Manufacturers (OCMs), and external suppliers.

This role serves as the CAPA subject matter expert and program coordinator within the Quality organization and is responsible for driving quality events to effective and sustainable resolution.

The QA CAPA Specialist ensures CAPAs are initiated, investigated, implemented, tracked, and closed in a timely and compliant manner, and partners closely with Manufacturing, QC, Engineering, Supplier Qualification, Procurement, and external partners.

This role requires structured root cause analysis, project management, and very strong communication skills to drive accountability across departments and external partners without direct authority.

• 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.
• Maintai…