Quality Assurance CAPA Specialist

About Thorne

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. Thorne is a team of more than 750 passionate individuals committed to 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. The role serves as the CAPA subject‑matter expert and program coordinator within the Quality organization, driving quality events to effective and sustainable resolution and ensuring CAPAs are initiated, investigated, implemented, tracked, and closed in a timely and compliant manner.

• Coordinate and govern Thorne’s CAPA process, ensuring compliance with internal procedures, cGMP requirements, and regulatory expectations.
• Serve as the primary point of contact for CAPA process questions, execution guidance, and continuous improvement.
• Ensure CAPAs are appropriately initiated from deviations, investigations, audits, complaints, OOS, supplier issues, and OCM quality events.
• Coordinate CAPA meetings and reviews, ensuring actions are clearly defined, risk‑based, and capable of preventing recurrence.
• Lead and support structured root‑cause analysis using appropriate methodologies, challenging inadequate or superficial investigations and driving deeper root‑cause identification when needed.
• Review corrective and preventive actions for technical adequacy and alignment to root cause.
• Verify CAPA effectiveness and ensure appropriate documentation and justification for closure.
• Coordinate CAPA implementation, progress, and closure for OCMs and external suppliers.
• Review supplier and OCM CAPA responses for completeness, technical soundness, and effectiveness.
• Partner with Supplier Qualification, Procurement, and QA leadership to elevate late, ineffective, or high‑risk external CAPAs.
• Support supply chain governance by ensuring external CAPAs are timely, risk‑based, and audit‑defensible.
• Build strong working relationships with Manufacturing, QC, Engineering, QA, Planning, Procurement, and external partners.
• Facilitate cross‑functional CAPA discussions and drive accountability for assigned actions.
• Provide clear and professional communication with internal teams, OCMs, and suppliers regarding CAPA expectations and status.
• Act as a quality advocate by challenging weak responses while maintaining productive working relationships.
• Ensure CAPA records are complete, accurate, traceable, and audit ready within the Quality Management System.
• Compile and maintain CAPA metrics, dashboards, and periodic reports for management review.
• Support internal audits, third‑party audits, and regulatory inspections by providing CAPA documentation and serving as CAPA SME.
• Proactively identify opportunities to improve CAPA workflows, templates, and tools.

• 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 preferred.
• Demonstrated experience in project management or complex cross‑functional initiatives preferred.
• Must be able to safely work with ingredients and products derived from possible allergenic sources (nuts, soy, dairy, fish, eggs, 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 time frames.
• Possesses good interpersonal skills and engages others in a positive manner.

• 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
• 401(k) 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

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER