Quality Assurance Document Control Specialist

Document Control & Quality Management Systems

• 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 timeframes.
• 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 available to Production within required timelines.
• Review completed batch order files to ensure all required documentation is present, accurate, and complete.
• Verify critical batch record information, including expiration dates, work order numbers, lot numbers, allergen identification, and other required documentation.
• Review batch records and receiving reports to support product disposition decisions.
• Ensure batch records and supporting quality documentation meet established GDP and cGMP requirements.
• Perform applicable quality transactions within Thorne's Enterprise Resource Planning (ERP) system, including product release activities.
• Conduct product release transactions for materials or products meeting established specifications and applicable requirements.
• Perform authorized batch certification responsibilities in accordance with applicable regulatory requirements and established procedures.
• Support final batch certification in coordination with the Marketing Authorization holder, ensuring required quality reviews are completed accurately and within established timelines.
• Maintain accurate batch order records, release documentation, and associated quality logs.
• Identify and escalate batch record discrepancies, missing documentation, or potential compliance concerns before product release.

Change Management & Document Revisions

• Receive, route, track, and maintain Change Requests within the Quality Management System.
• Coordinate the review, approval, implementation, and documentation of approved changes.
• Maintain accurate and complete change management records, including supporting documentation and implementation status.
• Update and complete applicable product checklists and route required actions to appropriate stakeholders.
• Partner with SMEs, department leaders, and other stakeholders to ensure document changes are implemented accurately and consistently.
• Monitor outstanding change management activities and follow up to support timely completion.
• Troubleshoot issues arising during document revision and change management processes.
• Provide guidance to internal teams regarding QMS change management requirements and workflows.
• Ensure approved document changes are appropriately finalized and recorded within the QMS.

• Scan, organize, file, archive, and maintain quality records in accordance with established record retention requirements.
• Maintain and update active Quality Assurance logs and provide required log information to appropriate stakeholders.
• Respond to Customer Service requests for Certificates of Analysis (COAs), coordinating with the Quality Control Laboratory when necessary.
• Ensure quality records are accurate, complete, legible, traceable, and maintained in accordance with applicable documentation requirements.
• Perform assigned activities in compliance with cGMP, GDP, Quality Assurance SOPs, and established company procedures.
• Maintain current knowledge of applicable procedures and regulatory requirements as they evolve.
• Support inspection and audit readiness through accurate documentation, effective record management, and compliant work practices.
• Identify documentation or compliance risks and promptly communicate concerns and recommended solutions.
• Maintain confidentiality and appropriate control of quality records and regulated documentation.

• Partner with Quality Assurance, Quality Control, Manufacturing, and other departments to support document control, batch record, and change management activities.
• Communicate documentation requirements, approval status, outstanding actions, and potential delays to appropriate stakeholders.
• Independently manage assigned projects and responsibilities within established guidelines and timelines.
• Identify opportunities to improve document accuracy, workflow efficiency, record management, and quality processes.
• Support resolution of document control and change management issues through collaboration with appropriate stakeholders.
• Provide clear and accurate documentation of completed work, findings, and process improvements.
• Maintain strong attention to detail while managing multiple documentation, quality, and operational priorities.
• Participate in required technical and quality training to maintain proficiency in applicable systems and procedures.

Education & Experience

• High school diploma or GED required.
• Relevant experience in Quality Assurance, document control, quality records management, manufacturing documentation, or a 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 working with ERP systems or performing quality-related system transactions preferred.
• Demonstrated ability to manage detailed documentation accurately and consistently.
• Ability to perform assigned responsibilities through an appropriate combination of education, training, and relevant experience.
  
  

Technical Knowledge

• 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, master manufacturing records, and related controlled documents.
• Ability to create, format, review, route, and maintain documentation within an electronic Quality Management System.
• 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 with established procedures.
• 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 and apply them accurately to assigned work.
• Understanding of product disposition, release documentation, and batch certification processes as applicable to assigned responsibilities.
  
  

Core Competencies

• Attention to Detail: Maintains a high level of accuracy when reviewing, creating, updating, and maintaining controlled documents and quality records.
  Quality & Compliance: Demonstrates a strong commitment to cGMP, GDP, established procedures, and accurate documentation practices.
• Organization & Prioritization: Effectively manages multiple documents, change requests, batch records, deadlines, and competing priorities.
  Problem Solving:Identifies documentation discrepancies, evaluates issues, and develops practical solutions within established guidelines.
  Accountability: Takes ownership of assigned responsibilities and follows projects and issues through to completion.
  Communication: Clearly communicates documentation requirements, quality concerns, process updates, and recommendations verbally and in writing.
  Cross-Functional Collaboration: Works effectively with Quality Assurance, Quality Control, Manufacturing, subject matter experts, and other stakeholders.
• Judgment & Escalation:Recognizes documentation, quality, or compliance concerns and promptly communicates issues requiring additional review.
• Initiative: Works independently within established procedures and proactively identifies opportunities for improvement.
• Technical Learning: Develops and maintains knowledge of quality systems, document control procedures, regulatory requirements, and supporting software.
• Data Integrity: Ensures documentation and quality records are accurate, complete, traceable, and appropriately maintained.
• Adaptability: Effectively adjusts to changing documentation priorities, manufacturing requirements, and quality processes.
• Continuous Improvement: Identifies opportunities to strengthen documentation practices, workflow efficiency, and overall QMS effectiveness.
  
  

PHYSICAL DEMANDS

• Ability to safely work in environments where ingredients and products may be derived from potentially allergenic sources, including nuts, soy, dairy, fish, and shellfish.
• Ability to remain in a stationary position for extended periods while performing computer-based document control, quality record review, and administrative activities.
• Ability to move throughout manufacturing, warehouse, quality, and administrative environments as required.
• Ability to safely and carefully operate assigned equipment and office machinery.
• Ability to communicate effectively with employees, supervisors, and cross-functional stakeholders.
• Ability to read and review detailed documentation, quality records, and small print in printed and electronic formats.
• Ability to work in an environment with moderate noise levels.
• Ability to occasionally lift or move items weighing up to 25 pounds between floor and table height.
• Ability to work an assigned 8-hour or 10-hour shift and overtime as business needs require.