Quality Assurance Document Control Specialist

Department:
Quality Assurance

Employment Type:

Full Time

Location:

Summerville, SC

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 is responsible for maintaining accurate, compliant, and well-organized controlled documents and quality records that support Thorne's Quality Management System (QMS) and manufacturing operations.

This role manages document control activities across standard operating procedures (SOPs), work instructions, forms, specifications, formulas, master manufacturing records, and other controlled documents. The Quality Assurance Document Control Specialist supports document creation, review, approval, distribution, maintenance, and archival while ensuring documentation remains accurate, current, traceable, and compliant with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

In addition to document control, this position supports batch record preparation and review, quality transactions, product release activities, change management, and quality record maintenance. Working closely with Quality Assurance, Quality Control, Manufacturing, and cross-functional subject matter experts, the specialist helps ensure documentation is complete, approved, and available to support compliant manufacturing and product disposition.

The ideal candidate is a highly organized, detail-oriented quality professional who understands the importance of document accuracy, data integrity, and regulatory compliance. This individual brings strong documentation skills, sound judgment, and the ability to manage multiple priorities while independently resolving issues and supporting continuous improvement within a regulated manufacturing environment.

Shift: Tuesday-Saturday 2nd Shift (3pm-11:30)

• Create, format, edit, route, finalize, file, and maintain controlled documents within Thorne's Quality Management System.
• Maintain controlled documentation, including SOPs, work instructions, forms, specifications, formulas, master manufacturing records, policies, and other quality-related documents.
• Coordinate with subject matter experts (SMEs) and cross-functional stakeholders to ensure controlled documents are accurate, complete, and appropriately reviewed.
• Ensure controlled documents progress through established review, approval, and finalization processes.
• Coordinate periodic document reviews and ensure required reviews are completed within established time frames.
• Maintain accurate document records, revision histories, and supporting documentation within the QMS.
• Ensure appropriate training documentation is completed for affected employees before revised controlled documents are released.
• Provide guidance and support to internal stakeholders regarding document control processes and QMS requirements.
• Identify documentation discrepancies, missing information, or process concerns and coordinate appropriate resolution.
• Support continuous improvement of document control processes, documentation accuracy, and overall QMS effectiveness.

• Create, review, and maintain manufacturing batch packets to support production activities.
• Verify that manufacturing job cards have the appropriate approved batch packets…