Production Document Specialist I
Job Location:
Summerville, SC - USA
Monthly Salary:
Not provided by the employer
Posted:
2 July 2026 (30+ days ago)
Application Deadline:
4 October 2026
Vacancies:
1 Vacancy
Job Summary
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 youll 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 Thornes 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 Thornes 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 Thornes 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 Thornes 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; Associates or Bachelors 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
Required Experience:
IC
About Company
We believe good health could always be made better. Shop Thorne's complete line of integrated health solutions