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Quality Assurance CAPA Specialist

Thorne

Job Location:

Summerville, SC - USA

Monthly Salary: Not provided by the employer

Posted: 21 August 2026 (24 days ago)

Application Deadline: 18 November 2026

Vacancies: 1 Vacancy

Job Summary

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 youll 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 Thornes 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.

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 Thornes 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 Thornes commitment to quality compliance and safety including taking appropriate action when product quality may be at risk.

WHAT YOU NEED

Bachelors 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