Quality Assurance Document Control Specialist- Entry Level

Quality Assurance Document Control Specialist- Entry Level

Department: Quality Assurance

Employment Type: Full Time

Location: Summerville, SC

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 I supports Thorne''s Quality Management System (QMS) by maintaining the accuracy, integrity, and lifecycle of controlled documents and quality records. This role is responsible for coordinating document creation, review, approval, distribution, revision, and archival activities to ensure documentation remains current, compliant, and readily accessible in accordance 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 Quality Assurance Document Control Specialist I helps ensure controlled documents-including Standard Operating Procedures (SOPs), work instructions, forms, specifications, master manufacturing records, formulas, and quality records-are managed accurately and efficiently throughout their lifecycle. The ideal candidate is highly organized, detail-oriented, and committed to maintaining documentation accuracy, regulatory compliance, and continuous improvement within a regulated manufacturing environment.

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

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.
• 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.

Technical Knowledge

• 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.

Core Competencies

• 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.

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.

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