Production Process Documentation Specialist bei Thorne

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

• Maintain a strong understanding of all relevant SOPs and current Good Manufacturing Practices (cGMP) related to production, safety, and quality.
• Ensure all documentation complies with applicable regulations and standards, including cGMP, HACCP, and FDA requirements. Assist with both internal and external audits as needed. Update the necessary documents to ensure compliance based on audit observations and findings.
• Support audit readiness and contribute to continuous improvement of documentation practices and tools.

Cross-Functional Collaboration

• Work closely with Operations to gather technical input, validate content, and ensure documentation reflects current procedures and best practices.
• Coordinate with departments across the organization to assist in the development, testing, and deployment of new and revised processes and materials.
• Organize, lead, and attend meetings in which input and/or feedback will be obtained from cross-functional teams that include the Subject Matter Experts (SMEs). Help determine solutions and propose ideas for implementation.
• Drive process improvement initiatives and support cross-functional projects by offering insights, making recommendations, and completing assigned tasks, including but not limited to:
  • Developing project charters
  • Conducting risk assessments
  • Preparing change control documentation
  • Creating training materials
  • Defining project milestones and timelines

Operational Support

• Accurately complete assigned tasks within defined timeframes and proactively communicate any issues that may impact deadlines.
• Assist with clerical and operational tasks as assigned, including room pressure checks, batch record reviews, Mom logs reviews, data collection, deviations, and reprocessing worksheets.
• Respond to emails and documentation requests in a timely and professional manner.
• The specialist may train employees using Teams, classroom sessions, or individual in-person settings.

What You Need  

• At least 4 years’ related experience or equivalent in higher education is required. High school diploma or general education degree (GED) required. 
• Experience with FDA, ISO and/or cGMP standards preferred.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Has a fundamental understanding of production processes and a working understanding of all areas within Operations.

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

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