Quality Assurance Document Control Specialist

Description

RESPONSIBILITIES

• Support the maintenance and administration of Thorne's Quality Management System (QMS) by assisting with document control and quality record management activities.
• Create, format, route, update, file, and maintain controlled documents, including Standard Operating Procedures (SOPs), work instructions, forms, specifications, master manufacturing records, and other quality documentation.
• Coordinate document reviews with Subject Matter Experts (SMEs) and cross-functional stakeholders to ensure documentation is accurate, complete, and current.
• Assist with the routing, tracking, and implementation of Change Requests within the Quality Management System while maintaining accurate change management records.
• Support periodic document reviews and ensure controlled documents are updated in accordance with established schedules and document control procedures.
• Create and maintain manufacturing batch packets, verifying documentation is complete and available to Production in a timely manner.
• Review batch records and supporting documentation for completeness and compliance with Good Documentation Practices (GDP), escalating discrepancies as appropriate.
• Support quality transactions within the Enterprise Resource Planning (ERP) system and maintain associated quality records and documentation.
• Scan, file, organize, and maintain quality records in accordance with document retention policies and regulatory requirements.
• Respond to internal requests for Certificates of Analysis (COAs) by coordinating with the Quality Control Laboratory and ensuring supporting documentation is available.
• Maintain quality logs, document control metrics, and other departmental records to support quality system activities.
• Provide day-to-day support for document control and change management processes while assisting internal stakeholders with document-related questions.
• Develop and maintain a working knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs), and Quality Management System requirements.
• Support internal audits, inspections, and continuous improvement initiatives by ensuring documentation is complete, accurate, and inspection-ready.
• Promote a culture of quality, collaboration, and continuous improvement 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.
• Previous experience in document control, quality assurance, manufacturing, administrative support, or a regulated environment is preferred but not required.
• Experience working in a cGMP, FDA-regulated, ISO, or other quality-focused environment is a plus.
• Familiarity with document management systems, Enterprise Resource Planning (ERP) systems, or electronic Quality Management Systems (eQMS) is preferred.

• Basic understanding of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), or the ability to quickly learn and apply quality system requirements.
• Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
• Ability to learn and effectively utilize ERP systems, document management systems, and electronic Quality Management Systems.
• Ability to accurately review, organize, and maintain documentation while ensuring attention to detail and document integrity.
• Basic mathematical and analytical skills with the ability to interpret written procedures, follow detailed instructions, and maintain accurate records.

• Exceptional attention to detail with a commitment to accuracy, organization, and regulatory compliance.
• Strong organizational and time management skills with the ability to prioritize multiple tasks and meet deadlines.
• Excellent verbal and written communication skills with the ability to collaborate effectively across Quality, Manufacturing, Operations, and other cross-functional teams.
• Strong interpersonal skills and a positive, collaborative approach to working with others.
• Demonstrated initiative with the ability to identify issues, ask questions, and recommend practical solutions.
• Ability to work independently while following established procedures and seeking guidance when appropriate.
• Eagerness to learn Quality Management System processes, document control principles, and regulatory requirements within a manufacturing environment.
• Commitment to continuous improvement, professional development, and delivering high-quality work.

• 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