Quality Assurance Document Control Specialist

Job Description

Job Description

Description

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 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.

Batch Record Management & Product Release

• 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.

• 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.

Quality Records, Compliance & Reporting

• 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.

Cross-Functional Collaboration & Continuous Improvement

• 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.

• 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.

• 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.

• 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.

The physical requirements described below are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform these essential functions.

• 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.

• Competitive compensation
• 100% company-paid medical, dental, and vision insurance coverage for employees
• Company-paid short- and long-term disability insurance
• Company- paid life insurance
• 401k plan with employer matching contributions up to 4%
• Gym membership reimbursement
• Monthly allowance of Thorne supplements
• Paid time off, volunteer time off and holiday leave
• Training, professional development, and career growth opportunities