Thorne
Production Process Documentation Specialist
Thorne, Summerville, South Carolina, United States, 29485
Overview
Production Process Documentation 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
Create, revise, and maintain production documentation to support manufacturing operations and ensure compliance. This includes SOPs, WIs, sanitation protocols, GMP forms, and Master Manufacturing Records (MMRs). Ensure 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 and develop or update documentation that reflects current practices and enhances operational efficiency.
Apply understanding of Good Documentation Practices (GDP), technical writing, and manufacturing experience to review, edit, and format documentation for accuracy, consistency, and compliance with FDA, cGMP, and ISO standards; ensure alignment with safety regulations 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 tasks are completed accurately and within timelines.
Compliance and Quality Assurance
Maintain understanding of relevant SOPs and current Good Manufacturing Practices (cGMP) related to production, safety, and quality.
Ensure all documentation complies with applicable regulations and standards (cGMP, HACCP, FDA). Assist with audits as needed and update documents 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 to assist in development, testing, and deployment of new and revised processes and materials.
Organize, lead, and participate in meetings with cross-functional teams including SMEs. Help determine solutions and propose implementation ideas.
Drive process improvement initiatives and support cross-functional projects by offering insights and completing tasks such as:
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 issues that may impact deadlines.
Assist with clerical and operational tasks as assigned, including room pressure checks, batch record reviews, 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 GED required.
Experience with FDA, ISO and/or cGMP standards preferred.
Ability to solve practical problems and interpret instructions furnished in written, oral, diagram, or schedule form.
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 an equal opportunity employer.
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Production Process Documentation 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
Create, revise, and maintain production documentation to support manufacturing operations and ensure compliance. This includes SOPs, WIs, sanitation protocols, GMP forms, and Master Manufacturing Records (MMRs). Ensure 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 and develop or update documentation that reflects current practices and enhances operational efficiency.
Apply understanding of Good Documentation Practices (GDP), technical writing, and manufacturing experience to review, edit, and format documentation for accuracy, consistency, and compliance with FDA, cGMP, and ISO standards; ensure alignment with safety regulations 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 tasks are completed accurately and within timelines.
Compliance and Quality Assurance
Maintain understanding of relevant SOPs and current Good Manufacturing Practices (cGMP) related to production, safety, and quality.
Ensure all documentation complies with applicable regulations and standards (cGMP, HACCP, FDA). Assist with audits as needed and update documents 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 to assist in development, testing, and deployment of new and revised processes and materials.
Organize, lead, and participate in meetings with cross-functional teams including SMEs. Help determine solutions and propose implementation ideas.
Drive process improvement initiatives and support cross-functional projects by offering insights and completing tasks such as:
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 issues that may impact deadlines.
Assist with clerical and operational tasks as assigned, including room pressure checks, batch record reviews, 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 GED required.
Experience with FDA, ISO and/or cGMP standards preferred.
Ability to solve practical problems and interpret instructions furnished in written, oral, diagram, or schedule form.
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 an equal opportunity employer.
#J-18808-Ljbffr