Quality Assurance Document Control Specialist Lead

Description

RESPONSIBILITIES

• 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.

WHAT YOU NEED

• 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.

• 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.

• 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.

• 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.

WHAT WE OFFER

• 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