Production Document Specialist I

Thorne

Summerville (SC)

On-site

USD 42,000 - 65,000

Full time

6 days ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Benefits offered by this job

Medical, dental, vision

Disability insurance

Life insurance

401k with match

Gym reimbursement

Supplements allowance

PTO & holidays

Training & development

Job summary

Thorne is seeking a Production Document Specialist I to support manufacturing by creating and maintaining controlled documentation in a cGMP environment. You will develop SOPs, WIs, and GDP/GMP forms, ensuring accuracy and regulatory compliance across processes.

The role requires attention to detail, organization, and ability to work with SMEs and cross-functional teams in a fast-paced setting.

Qualifications

High school diploma or GED required; Associate's or Bachelor's degree in Technical Writing, Manufacturing, Quality, Life Sciences, Business, or related field preferred.
1-3 years of experience in document control, technical writing, manufacturing support, quality systems, or regulated manufacturing environment preferred.
Experience in FDA-, ISO-, or cGMP-regulated environments preferred.
Experience with electronic QMS or document workflows is a plus.

Responsibilities

Develop and maintain SOPs, WIs, GMP forms and related controlled documents in collaboration with SMEs and operations.
Route documents through QMS, monitor approval workflows, and ensure timely completion per procedures.
Collaborate with Production, Quality, Engineering to reflect current processes and regulatory requirements in documentation.
Periodically review documents with SMEs to keep content current and compliant.
Support production operations to maintain process knowledge and documentation accuracy.

Skills

GDP knowledge

cGMP knowledge

Documentation

Microsoft Office

Quality systems

Education

High school diploma or GED

Technical/Manufacturing/Quality degree preferred

Tools

eQMS

Document management systems

Job description

Production Document Specialist I

Department: Production Support - Supply Chain

Employment Type: Full Time

Location: Summerville, SC

Description

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.

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