Quality Assurance CAPA Specialist

Responsibilities

• 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.
• 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.

Requirements

• 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 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.

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