Document Control Specialist I – GMP/GDP (Production)

Thorne; Summerville (SC); On-site; USD 42,000 - 65,000; Full time

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

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.