Quality Assurance Document Control Specialist

About the role

Thorne is hiring a Quality Assurance Document Control Specialist in Summerville. The specialist maintains accurate, compliant and well-organized controlled documents and quality records that support the company's Quality Management System (QMS) and manufacturing operations. The role covers document control across SOPs, work instructions, forms, specifications, formulas, master manufacturing records and other controlled documents, and also supports batch record preparation and review, quality transactions, product release, change management and quality record maintenance. It works closely with Quality Assurance, Quality Control, Manufacturing and cross-functional subject matter experts.

Key responsibilities

• Create, format, edit, route, finalize, file and maintain controlled documents in the QMS, including SOPs, work instructions, forms, specifications, formulas, master manufacturing records, policies and quality-related documents.
• Coordinate document reviews with subject matter experts and stakeholders, keeping records, revision histories and training documentation up to date.
• Create, review and maintain manufacturing batch packets and job cards, verify batch records and receiving reports, and perform quality transactions and product release in the ERP system.
• Perform authorized batch certification and support final batch certification with the Marketing Authorization holder.
• Receive, route, track and maintain Change Requests, coordinate review, approval and implementation of changes, and monitor outstanding change activities.
• Scan, organize, archive and maintain quality records, keep QA logs updated, and respond to customer requests for Certificates of Analysis.
• Support inspection and audit readiness, identify documentation or compliance risks, and escalate batch record discrepancies before product release.

Required profile

• Highly organized, detail-oriented quality professional with strong documentation skills and sound judgment.
• Ability to manage multiple priorities and resolve issues independently in a regulated manufacturing environment.
• Understanding of document accuracy, data integrity and regulatory compliance.

The position is on the 2nd shift, Tuesday to Saturday, 3pm to 11:30pm.