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 Lead is responsible for leading and maintaining Thorne's document control program, ensuring the integrity, accuracy, and lifecycle management of controlled documents within the Quality Management System (QMS). This role oversees document creation, review, approval, revision, distribution, archival, and record retention to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards.
Working closely with Quality Assurance, Manufacturing, Regulatory Affairs, Engineering, Product Development, and other cross-functional teams, the QA Document Control Specialist Lead serves as the primary resource for document control processes and governance. This individual drives continuous improvement initiatives, supports regulatory inspections and audits, and ensures controlled documents—including Standard Operating Procedures (SOPs), work instructions, specifications, forms, formulas, master manufacturing records, and quality records—remain accurate, current, and readily accessible throughout their lifecycle.
- Lead and oversee document control activities within Thorne's Quality Management System (QMS), ensuring controlled documents are accurate, current, and compliant throughout their lifecycle.
- Create, format, review, route, approve, issue, archive, and maintain controlled documents, including Standard Operating Procedures (SOPs), work instructions, forms, specifications, policies, master manufacturing records, and other quality documentation.
- Coordinate document reviews with Subject Matter Experts (SMEs) and cross-functional stakeholders to ensure documentation accurately reflects current processes and regulatory requirements.
- Manage document revision schedules and periodic document reviews to ensure controlled documents remain current and compliant with internal procedures and regulatory expectations.
- Receive, coordinate, track, and implement Change Requests through the Quality Management System, ensuring changes are properly reviewed, approved, documented, and communicated.
- Serve as the primary resource for document control and change management processes, providing guidance, troubleshooting support, and training to internal stakeholders.
- Ensure document revisions are appropriately communicated and that required employee training is completed and documented prior to implementation.
- Create, review, and maintain manufacturing batch packets, verifying documentation is complete, accurate, and available to Production in accordance with established schedules.
- Review batch records, receiving reports, and supporting quality documentation to ensure completeness, compliance with Good Documentation Practices (GDP), and readiness for product disposition and release.
- Perform quality transactions within the Enterprise Resource Planning (ERP) system, including product release activities and maintenance of associated quality records.
- Support final batch disposition activities by verifying documentation accuracy, maintaining quality records, and ensuring products meet applicable specifications and regulatory requirements prior to release.
- Maintain quality records, document control logs, and key performance metrics while generating status reports that support operational visibility and continuous improvement.
- Coordinate with third-party certification organizations, internal teams, and external partners to support certification activities and maintain required documentation.
- Respond to customer requests for Certificates of Analysis (COAs) by coordinating with the Quality Control Laboratory and ensuring accurate documentation is provided in a timely manner.
- Support internal and external audits, mock recalls, regulatory inspections, and quality system initiatives by ensuring documentation is complete, organized, and inspection-ready.
- Identify opportunities to improve document control, change management, and quality system processes, implementing solutions that improve efficiency, compliance, and operational effectiveness.
- Promote a culture of quality, collaboration, continuous improvement, and regulatory compliance while performing other duties as assigned.
Education & Experience
- High school diploma or GED required; Associate's or Bachelor's degree in Quality, Life Sciences, Manufacturing, Business, or a related field preferred.
- Experience supporting document control, quality systems, or quality assurance within a cGMP-regulated manufacturing environment required.
- Experience managing controlled documents, change control, and quality records within a Quality Management System (QMS).
- Experience supporting batch record review, product release, document control, or quality systems activities is preferred.
- Experience working with Enterprise Resource Planning (ERP) systems and electronic Quality Management Systems (eQMS) is preferred.
Technical Knowledge
- Working knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), document control principles, and quality systems.
- Experience managing the lifecycle of controlled documents, including creation, review, approval, revision, issuance, archival, and record retention.
- Understanding of change control processes, document governance, and regulatory compliance within a manufacturing environment.
- Proficiency with Microsoft Office Suite and the ability to effectively utilize ERP, document management, and electronic Quality Management Systems.
- Familiarity with batch record documentation, product release processes, third-party certifications, and regulatory inspection readiness is preferred.
Core Competencies
- Exceptional organizational skills with the ability to manage multiple priorities, competing deadlines, and complex document workflows.
- Strong attention to detail with a commitment to accuracy, data integrity, and regulatory compliance.
- Excellent verbal and written communication skills with the ability to collaborate effectively across Quality, Manufacturing, Regulatory Affairs, Operations, and other cross-functional teams.
- Demonstrated ability to identify process improvement opportunities, solve problems, and implement practical solutions that improve quality system performance.
- Ability to work independently while providing technical guidance and support on document control and change management processes.
- Strong interpersonal skills with the ability to build relationships, influence stakeholders, and support cross-functional collaboration.
- Demonstrated initiative, sound judgment, and a commitment to continuous improvement and operational excellence.
Physical Demands
The physical requirements described below are representative of those that must be met 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 with ingredients and products derived from common allergens, including nuts, soy, dairy, fish, and shellfish.
- Ability to remain in a stationary position and move throughout office, manufacturing, warehouse, and laboratory environments as needed.
- Ability to safely operate standard office equipment and computer systems used to support document control and quality system activities.
- Ability to communicate effectively, read printed and electronic documentation, and review detailed records and small print.
- Ability to work in a moderate-noise manufacturing environment and work scheduled shifts, including overtime as needed.
- Ability to occasionally lift and move materials weighing up to 25 pounds.
