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Thorne is a health and wellness company delivering science-backed solutions to empower individuals to take a proactive approach to their well-being. 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.
Key responsibilities include:
**Document Control & Quality Management Systems:** Create, format, edit, route, finalize, file, and maintain controlled documents within the QMS, including SOPs, work instructions, forms, specifications, formulas, and master manufacturing records. Coordinate with subject matter experts and cross-functional stakeholders to ensure documents are accurate and complete. Manage document reviews, revision histories, and training documentation. Provide guidance to internal stakeholders on document control processes and identify documentation discrepancies for resolution.
**Batch Record Management & Product Release:** Create, review, and maintain manufacturing batch packets. Verify that manufacturing job cards have appropriate approved batch packets available to Production within required timelines. Review completed batch order files for completeness and accuracy. Verify critical batch record information including expiration dates, work order numbers, lot numbers, and allergen identification. Support product disposition decisions and perform quality transactions within the ERP system. Conduct product release transactions and support final batch certification.
**Change Management & Document Revisions:** Receive, route, track, and maintain Change Requests within the QMS. Coordinate review, approval, implementation, and documentation of approved changes. Maintain accurate change management records and update applicable product checklists. Partner with SMEs and department leaders to ensure document changes are implemented accurately.
**Quality Records, Compliance & Reporting:** Scan, organize, file, archive, and maintain quality records in accordance with retention requirements. Maintain QA logs and respond to Customer Service requests for Certificates of Analysis. Ensure records are accurate, complete, legible, and traceable. Perform work in compliance with cGMP, GDP, and company procedures. Support inspection and audit readiness.
**Cross-Functional Collaboration:** Partner with Quality Assurance, Quality Control, Manufacturing, and other departments. Communicate documentation requirements and approval status. Independently manage assigned projects. Identify opportunities for process improvement.
Shift: Tuesday-Saturday, 2nd Shift (3pm-11:30pm)
**Requirements:**
- High school diploma or GED required
- Relevant experience in Quality Assurance, document control, quality records management, manufacturing documentation, or related discipline preferred
- Experience working within a cGMP-regulated manufacturing environment preferred
- Familiarity with controlled documents, quality records, batch documentation, and document review processes preferred
- Experience with electronic Quality Management Systems, document management systems, or change management workflows preferred
- Experience with ERP systems or performing quality-related system transactions preferred
- Demonstrated ability to manage detailed documentation accurately and consistently
- Working knowledge of document control principles, controlled documentation, quality records, and record retention practices
- Understanding of cGMP and GDP requirements as they apply to quality documentation and manufacturing records
- Familiarity with SOPs, work instructions, specifications, forms, and master manufacturing records
- Ability to create, format, review, route, and maintain documentation within an electronic QMS
- Understanding of document revision, change management, review, approval, and archival processes
- Knowledge of batch record preparation, review, and documentation requirements
- Ability to review manufacturing and quality records for completeness, accuracy, and compliance
- Ability to perform or learn quality-related transactions within an ERP system
- Proficiency with Microsoft Word and Excel
- Ability to learn and effectively use Thorne's ERP, document management, and change management systems
- Ability to perform basic mathematical calculations involving whole numbers and decimals
- Ability to interpret written procedures, technical documentation, and quality requirements
- Understanding of product disposition, release documentation, and batch certification processes
- Core competencies: attention to detail, quality & compliance commitment, organization & prioritization, problem solving, accountability, clear communication, cross-functional collaboration, sound judgment, initiative, technical learning, data integrity, adaptability, and continuous improvement mindset
