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Theo — Summerville, South Carolina
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 Document Control Specialist I supports Thorne's Quality Management System (QMS) by maintaining the accuracy, integrity, and lifecycle of controlled documents and quality records.
Requirements
, and internal quality standards. Working closely with Quality Assurance, Manufacturing, Regulatory Affairs, Engineering, Product Development, and other cross-functional teams, the Quality Assurance Document Control Specialist I helps ensure controlled documents—including Standard Operating Procedures (SOPs), work instructions, forms, specifications, master manufacturing records, formulas, and quality records—are managed accurately and efficiently throughout their lifecycle. The ideal candidate is highly organized, detail-oriented, and committed to maintaining documentation accuracy, regulatory compliance, and continuous improvement within a regulated manufacturing environment.
Support the maintenance and administration of Thorne's Quality Management System (QMS) by assisting with document control and quality record management activities. Create, format, route, update, file, and maintain controlled documents, including Standard Operating Procedures (SOPs), work instructions, forms, specifications, master manufacturing records, and other quality documentation. Coordinate document reviews with Subject Matter Experts (SMEs) and cross-functional stakeholders to ensure documentation is accurate, complete, and current.
Assist with the routing, tracking, and implementation of Change Requests within the Quality Management System while maintaining accurate change management records. Support periodic document reviews and ensure controlled documents are updated in accordance with established schedules and document control procedures. Create and maintain manufacturing batch packets, verifying documentation is complete and available to Production in a timely manner.
Review batch records and supporting documentation for completeness and compliance with Good Documentation Practices (GDP), escalating discrepancies as appropriate. Support quality transactions within the Enterprise Resource Planning (ERP) system and maintain associated quality records and documentation.
Respond to internal requests for Certificates of Analysis (COAs) by coordinating with the Quality Control Laboratory and ensuring supporting documentation is available. Maintain quality logs, document control metrics, and other departmental records to support quality system activities. Provide day-to-day support for document control and change management processes while assisting internal stakeholders with document-related questions.
Support internal audits, inspections, and continuous improvement initiatives by ensuring documentation is complete, accurate, and inspection-ready. Promote a culture of quality, collaboration, and continuous improvement while performing other duties as assigned.