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Open nowFirst seen 19 hours ago

Quality Assurance CAPA Specialist

Thorne39 open roles

Where
Summerville, South Carolina
Work mode
On site
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Your applicationOpen nowQuality Assurance CAPA SpecialistThorne · Summerville, South Carolina

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This job: first seen 19 hours ago

The posting

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 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.

RESPONSIBILITIES

  • Coordinates and governs Thorne’s CAPA process, ensuring compliance with internal procedures, cGMP requirements, and regulatory expectations.
  • Serves as the CAPA subject matter expert and primary contact for process guidance, training, and continuous improvement.Ensures CAPAs are appropriately initiated from deviations, investigations, audits, complaints, OOS, supplier issues, and OCM quality events.
  • Facilitates CAPA meetings and reviews, and ensures actions are clearly defined, risk-based, and capable of preventing recurrence.
  • Reviews CAPA plans for technical adequacy, risk-based decision-making, clear ownership, and realistic timelines.
  • Leads and supports structured root cause analysis using appropriate methodologies.
  • Challenges inadequate or superficial investigations and drive deeper root cause identification when needed.
  • 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. 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.
  • 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.
  • Provides guidance and informal training to internal teams, OCMs, and suppliers on CAPA best practices.
  • Stays current on regulatory expectations, industry trends, and best practices related to CAPA and quality systems.
  • Becomes thoroughly knowledgeable of applicable SOPs and cGMPs and maintains knowledge without reliance on management direction.
  • Provides quality review and feedback on new products and processes as required.
  • Participates in process improvement teams to provide quality input and direction.
  • Ensures compliance with cGMP, FDA, OSHA, and all other regulatory requirements.

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 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 strongly preferred.
  • Demonstrated experience in project management or complex cross-functional initiatives preferred.
  • Ability to effect change in a positive environment. Must be able to provide constructive arguments and sound justification as it pertains to technical and supplier requirements.
  • Initiates and completes reports in a timely manner

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
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