Production Process Documentation Specialist

Job Description

Job 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.

Position Summary : The Production Process Document Specialist supports Thorne’s manufacturing operations and continuous improvement goals. The specialist develops processes related to equipment, cleaning, and manufacturing and creates, revises, and maintains high-quality documentation, such as Standard Operating Procedures (SOPs), Work Instructions (WIs), sanitation protocols, GMP forms, and other documents. The specialist directly observes processes, interviews subject matter experts and collaborates with cross-functional teams to translate complex procedures into user- friendly documentation. Additionally, the specialist edits, formats, and standardizes both new and existing documents to ensure they comply with internal documentation standards and meet regulatory requirements, including cGMP, HACCP, and FDA guidelines.

Responsibilities

Documentation Development & Maintenance

• Create, revise, and maintain production documentation to support manufacturing operations and ensure compliance. This includes Standard Operating Procedures (SOPs), Work Instructions (WIs), sanitation protocols, GMP forms, and Master Manufacturing Records (MMRs). Ensure all materials are clear, structured, and aligned with internal formatting standards and regulatory guidelines.
• Conduct on-site observations of production activities, equipment operation, and workflow processes to gather accurate, real-time information. Use these insights to develop or update documentation that accurately reflects current practices and enhances operational efficiency.
• Apply a strong understanding of Good Documentation Practices (GDP), technical writing principles, and manufacturing experience to review, edit, and format documentation to ensure documentation is accurate, consistent, and fully compliant with FDA, cGMP, and ISO standards. Ensure all materials align with safety regulations, operational procedures, and internal formatting guidelines.
• Support documentation systems by submitting Change Requests, assisting with documentation reviews and approvals, and conducting Periodic Reviews of controlled documents within the Quality Management System (QMS). Ensure all tasks are completed accurately and within designated timelines.

Compliance and Quality Assurance

Cross-Functional Collaboration

Developing project charters

Operational Support

What You Need

What We Offer

Please Note : All employees must be able to safely work with ingredients and products that are derived from possibly allergenic sources including, but not limited to, nuts, soy, dairy, fish, and shellfish.

Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com.

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER