The Role
Drafts and revises controlled manufacturing documents (SOPs, WIs, GMP forms) to ensure cGMP/GDP compliance. Coordinates QMS reviews, performs periodic record reviews, supports production teams, leads cross-functional meetings, and assists with clerical and production support tasks to maintain accurate, current documentation.
Summary Generated by Built In
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.
The Production Document Specialist I supports Thorne's manufacturing operations by creating, revising, and maintaining controlled production documentation that ensures accuracy, consistency, and compliance across manufacturing processes. This role is responsible for developing and updating Standard Operating Procedures (SOPs), Work Instructions (WIs), GMP forms, and other controlled documents that support efficient production and regulatory compliance.
The Production Document Specialist I supports Thorne's manufacturing operations by creating, revising, and maintaining controlled production documentation that ensures accuracy, consistency, and compliance across manufacturing processes. This role is responsible for developing and updating Standard Operating Procedures (SOPs), Work Instructions (WIs), GMP forms, and other controlled documents that support efficient production and regulatory compliance.
Working closely with Production, Quality, Operations, and other cross-functional teams, the Production Document Specialist I helps ensure manufacturing documentation reflects current processes, meets Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP) requirements, and supports the consistent production of Thorne's high-quality products. The ideal candidate is detail-oriented, organized, and committed to maintaining documentation accuracy in a fast-paced, regulated manufacturing environment.
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
Education & Experience
- 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.
Technical Knowledge
- 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.
Core Competencies
- 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
About
We specialize in delivering innovative solutions and exceptional services to meet the diverse needs of our clients. With a strong commitment to quality and customer satisfaction, we strive to exceed expectations and drive success in every project we undertake.
Skills Required
- High school diploma or GED
- Working knowledge of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP)
- Experience using Microsoft Office applications (Word, Excel, Outlook)
- Ability to interpret technical processes and translate them into clear documentation
- Strong written and verbal communication skills
- Ability to prioritize tasks and meet deadlines in a manufacturing environment
- 1-3 years experience in document control, technical writing, manufacturing support, quality systems, or regulated environments
- Experience in FDA, ISO, and/or cGMP-regulated environments
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The Company
What We Do
We’re a team of dreamers, scientists, doctors, and health enthusiasts – all working toward the same goal – helping every individual discover and achieve their best possible health. We do it by creating innovative health solutions and by owning every process, from R&D to product delivery and customer service. We intend to defy expectations of good health through home testing technology, dietary and lifestyle education, and superior nutritional products.
