Quality Assurance Specialist I

Quality Assurance Specialist I

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) Specialist I is responsible and accountable for quality tasks and operations. Possesses and applies a broad knowledge of Quality principles, practices, and procedures. Supports Change Control process, Corrective and Preventive Action (CAPA) system, deviation process, nonconforming material process, product stability program, customer complaints, adverse events, supplier qualification process, internal audit process and third-party audit process. Works with the Material Review Board, Purchasing, and Suppliers to resolve product issues.

RESPONSIBILITIES

• Partner cross-functionally with Purchasing, Engineering, Planning, R&D, Sales, and Quality teams to support contract manufacturing activities and maintain supply chain quality and integrity.
• Investigate, coordinate, and resolve supplier quality issues, including root cause analysis, corrective actions, and follow-up activities.
• Maintain and communicate supplier quality and complaint status reports to stakeholders.
• Manage customer complaint investigations from initiation through resolution, including documentation of findings, root causes, and CAPAs when applicable.
• Coordinate supplier qualification activities, including supplier approvals/disapprovals, quality agreements, and supplier audits.
• Conduct onsite and remote audits of contract manufacturers and key suppliers to ensure compliance with quality standards and regulatory requirements.
• Monitor and review product stability data for both normal and accelerated studies; communicate any trends, anomalies, or potential risks to Quality Management and key stakeholders.
• Maintain a strong working knowledge of SOPs, cGMPs, and applicable quality regulations, staying current as procedures evolve.
• Support continuous improvement initiatives by identifying opportunities to streamline systems, strengthen processes, and improve overall product quality.
• Plan, participate in, and follow up on internal audits and inspections across departments and operational processes.
• Write, review, and revise SOPs, specifications, controlled forms, and related quality documentation to ensure accuracy, compliance, and alignment with current operations.
• Coordinate CAPA activities, including meetings, documentation management within EtQ, root cause investigations, and development of corrective and preventive actions.
• Perform raw material evaluations to assess alignment between supplier specifications and internal requirements, identifying and communicating potential quality risks.
• Conduct Product Quality Reviews (PQRs) for Australia products and designated Thorne core products.
• Participate in cross-functional process improvement teams, ensuring quality considerations and documentation requirements are properly addressed.
• Maintain accurate, detailed, and compliant records and documentation.
• Demonstrate sound judgment and a commitment to product quality, including the ability to stop a process or procedure when quality or SOP compliance is in question.
• Adhere to company safety standards and contribute innovative ideas to improve processes, systems, and overall quality performance.

WHAT YOU NEED

• Bachelor's degree with two years of related experience; or equivalent combination of education and experience.
• Must be able to lead and work with cross-functional teams and track projects to completion.
• Requires experience in a cGMP manufacturing environment plus demonstrated familiarity with standard quality concepts, practices, and procedures.
• 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.
• Schedules projects and meets tight deadlines.
• Ability to travel up to 5 - 10% of the time.

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