Production Process Documentation Specialist

Thorne Research Inc-posted 3 months ago

Full-time • Mid Level

Summerville, SC

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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.

Create, revise, and maintain production documentation to support manufacturing operations and ensure compliance.
Conduct on-site observations of production activities, equipment operation, and workflow processes to gather accurate, real-time information.
Apply a strong understanding of Good Documentation Practices (GDP), technical writing principles, and manufacturing experience to review, edit, and format documentation.
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).
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.
Support audit readiness and contribute to continuous improvement of documentation practices and tools.
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.
Drive process improvement initiatives and support cross-functional projects by offering insights, making recommendations, and completing assigned tasks.
Accurately complete assigned tasks within defined timeframes and proactively communicate any issues that may impact deadlines.
Assist with clerical and operational tasks as assigned.
Respond to emails and documentation requests in a timely and professional manner.
Train employees using Teams, classroom sessions, or individual in-person settings.

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.
Has a fundamental understanding of production processes and a working understanding of all areas within Operations.

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

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