Production Document Specialist I

Description

RESPONSIBILITIES

• Develop and maintain a thorough understanding of Thorne's manufacturing processes, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and Good Documentation Practices (GDP) to support accurate and compliant production documentation.
• Develop expertise in at least two manufacturing areas while maintaining working knowledge of all production operations to effectively support documentation activities.
• Draft, revise, and maintain controlled manufacturing documents, including Standard Operating Procedures (SOPs), Work Instructions (WIs), GMP forms, and related documentation in collaboration with Subject Matter Experts (SMEs) and operational teams.
• Route controlled documents through the Quality Management System (QMS), monitor approval workflows, and follow up with stakeholders to ensure timely completion in accordance with document control procedures.
• Collaborate with Production, Quality, Engineering, and other cross-functional teams to verify documentation accurately reflects current manufacturing processes, equipment, and regulatory requirements.
• Conduct periodic reviews of assigned controlled documents, coordinating updates with SMEs to ensure documentation remains current, accurate, and compliant.
• Organize and facilitate cross-functional meetings to gather feedback, resolve documentation questions, and align on technical and procedural changes.
• Support production operations by performing assigned manufacturing support activities to maintain process knowledge and strengthen documentation accuracy.
• Maintain document accuracy, traceability, and compliance with GDP, cGMP, and internal quality standards throughout the document lifecycle.
• Prioritize multiple assignments, monitor project progress, and communicate documentation issues or compliance concerns that may impact production schedules or regulatory requirements.
• Assist with documentation corrections, data collection, and other administrative or production support activities as needed.
• Perform other duties as assigned.

WHAT YOU NEED

• High school diploma or GED required; Associate's or Bachelor's degree in Technical Writing, Manufacturing, Quality, Life Sciences, Business, or a related field preferred.
• One to three years of experience in document control, technical writing, manufacturing support, quality systems, or a regulated manufacturing environment preferred.
• Experience working in FDA-, ISO-, or cGMP-regulated environments is preferred.
• Experience working with electronic Quality Management Systems (eQMS), document management systems, or controlled document workflows is a plus.

• Working knowledge of Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), and document control principles.
• Ability to interpret manufacturing processes, technical procedures, and regulatory requirements and translate them into clear, accurate, and compliant documentation.
• Proficiency with Microsoft Office Suite, including Word, Excel, and Outlook.
• Experience reviewing, formatting, and maintaining controlled documents while ensuring accuracy, consistency, and version control.
• Strong attention to detail with the ability to identify documentation discrepancies and support timely resolution.

• Excellent written and verbal communication skills with the ability to collaborate effectively across Production, Quality, Engineering, and other cross-functional teams.
• Strong organizational and time management skills with the ability to prioritize multiple assignments and consistently meet deadlines.
• Demonstrated analytical and problem-solving skills with sound judgment and a proactive approach to identifying documentation improvements.
• Ability to work independently while managing competing priorities in a fast-paced, regulated manufacturing environment.
• Collaborative, detail-oriented, and committed to producing accurate, high-quality documentation that supports operational excellence and regulatory compliance.
• Commitment to continuous learning, process improvement, and maintaining documentation integrity throughout the document lifecycle.

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