Quality Assurance CAPA Specialist

Thorne; Summerville (SC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Disability insurance

Life insurance

401k plan with employer matching

Gym membership reimbursement

Supplements allowance

Paid time off

Job summary

Thorne in Summerville, SC is seeking a Quality Assurance CAPA Specialist to drive corrective and preventive actions across internal manufacturing, outside contract manufacturers, and suppliers. You will serve as CAPA subject matter expert, coordinating investigations, root cause analysis, and action plans with cross-functional teams.

The role demands strong project management, structured problem solving, and excellent communication to ensure timely, compliant CAPAs and audit readiness.

Qualifications

• Bachelor’s degree or equivalent in a scientific/engineering/quality discipline.
• 5+ years of quality experience, with at least 3 years supporting CAPA activities.
• Experience overseeing CAPAs for external partners (OCMs/suppliers).
• Demonstrated project management and cross-functional collaboration capabilities.

Responsibilities

• Lead CAPA process from initiation to closure, ensuring alignment with cGMP and regulatory expectations.
• Serve as CAPA subject matter expert; guide investigations, root cause analysis, corrective and preventive actions.
• Review CAPAs for effectiveness, maintain audit-ready records, and coordinate with internal/external partners.
• Facilitate CAPA meetings and cross-functional discussions with clear, risk-based actions.

Skills

CAPA management

Root cause analysis

Project management

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in science/engineering/quality

Tools

QA/ CAPA software

Job description

Quality Assurance CAPA Specialist

Department: Quality Assurance

Employment Type: Full Time

Location: Summerville, SC

Description

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.

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