Thorne · 23 hours ago
Quality Assurance CAPA Specialist
SUMMERVILLE, SC, US
Full-time
Onsite
Senior Level
7+ years expThorne is a leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. The Quality Assurance CAPA Specialist is responsible for executing and governing Thorne’s Corrective and Preventive Action (CAPA) program, ensuring compliance and driving quality events to resolution.
Dietary SupplementsHealth CareHealth DiagnosticsNutrition
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
Qualification
Required
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
Preferred
Experience supporting or overseeing CAPAs for OCMs and/or suppliers strongly preferred
Demonstrated experience in project management or complex cross-functional initiatives preferred
Benefits
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
Company
Thorne
We’re a team of dreamers, scientists, doctors, and health enthusiasts – all working toward the same goal – helping every individual discover and achieve their best possible health.
201-500 employees
H1B Sponsorship
Thorne has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-02-25Acquired
2018-07-09Series Unknown
2010-01-01Private Equity
Leadership Team
Colin Watts
Chief Executive Officer
Bob Rountree, MD
Chief Medical Officer
Recent News
Canada NewsWire
2026-01-13
Company data provided by crunchbase