Quality Assurance CAPA Specialist

Thorne Research Inc•Summerville, SC

About The Position

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. Position Summary: 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 strong working knowledge of cGMP quality systems, structured root cause analysis, project management, and very strong communication skills to drive accountability across departments and external partners without direct authority. This position requires <50% travel.

Requirements

Education and Experience: 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.
Must be able to safely work with ingredients and products that are derived from possible allergenic sources including but not limited to nuts, soy, dairy, fish, eggs and shellfish.
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.

Nice To Haves

Experience supporting or overseeing CAPAs for OCMs and/or suppliers strongly preferred.
Demonstrated experience in project management or complex cross-functional initiatives preferred.

Responsibilities

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 drive 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 (e.g., EtQ, MasterControl, etc.).
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