Production Document Specialist I

Thorne • Summerville, SC

1d • Onsite

About The Position

The Production Document Specialist I is responsible for drafting and revising controlled manufacturing documentation in support of Production. This role contributes to the creation and revision of Standard Operating Procedures (SOPs), Work Instructions (WIs), GMP Forms, and related documentation within a regulated manufacturing environment. The position requires foundational technical document experience and a working knowledge of Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).

Requirements

• High school diploma or GED required.
• One to three years of experience in document control, technical writing, document control, manufacturing support, quality systems, or a regulated environment preferred.
• Experience in FDA, ISO, and/or cGMP-regulated environments preferred.
• The employee must be able to perform the essential duties of the position based on a combination of education, training, and experience.
• Experience using Microsoft Office applications (Word, Excel, Outlook) required.
• Able to read and understand at a technical and proficient level.
• The employee follows instructions, both verbal and written, and communicates effectively with supervisors and fellow employees.
• Has the ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Has the ability to add, subtract, multiply, and divide in all units of measurement, using whole numbers and decimals.
• Demonstrates 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 structured manufacturing environment.

Responsibilities

• Become knowledgeable of all Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) relating to production, area safety, procedures, and processes.
• Develop a comprehensive understanding of a minimum of two manufacturing areas while maintaining working familiarity across all production operations to support technically accurate and compliant documentation.
• Draft controlled documents with team and leadership guidance to accurately reflect current manufacturing processes, equipment, and regulatory requirements, incorporating input from Subject Matter Experts and aligning with established company standards.
• Route documentation through the Quality Management System (QMS) for formal review and approval, monitor status, and follow up as needed to support timely progression in accordance with established document control procedures.
• Maintain adherence to Good Documentation Practices (GDP), cGMP requirements, and internal document control standards to ensure consistency, accuracy, and traceability.
• Work with Production, Quality, and other operational teams to verify that documentation reflects accurate, complete, and current information.
• Conduct scheduled Record Reviews (Periodic Reviews) of assigned documents, coordinate necessary updates with Subject Matter Experts, and ensure revisions are completed within established timeframes.
• Assist in clerical tasks as assigned. Tasks may include but are not limited, to documentation corrections and data collection.
• Accurately complete assigned tasks in a reasonable or defined timeframe and quickly communicate issues that may prevent timely completion.
• Organize and lead cross-functional meetings related to document development or revision, gather feedback, and ensure alignment on technical and procedural updates.
• Perform assigned production support tasks within various manufacturing areas as needed to support operations and to maintain operational alignment and process understanding.
• Prioritize and tracks assignments to meet established deadlines while maintaining documentation accuracy.
• Communicate documentation issues or compliance concerns that may impact regulatory requirements or production timelines to support timely resolution.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED