QA Document Control & Batch Records Specialist

Thorne; Summerville (SC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation

100% company-paid medical, dental, and

Vision insurance for employees

Company-paid disability insurance

Company-paid life insurance

401k plan with employer matching

Gym membership reimbursement

Monthly Thorne supplement allowance

Paid time off, volunteer time off and

Training, professional development, &"

Job summary

Thorne is seeking a Quality Assurance Document Control Specialist in Summerville, SC, to manage controlled documents, batch records, and change management within the QMS. The role emphasizes accuracy, data integrity, and regulatory compliance in a cGMP environment.

You will collaborate with Quality Assurance, Quality Control, and Manufacturing teams to ensure documentation is current, traceable, and ready for product disposition.

Qualifications

• High school diploma or GED required.
• Experience in Quality Assurance, document control, quality records management, manufacturing documentation, or a related discipline preferred.
• Experience working within a cGMP-regulated manufacturing environment preferred.
• Familiarity with controlled documents, quality records, batch documentation, and document review processes preferred.

Responsibilities

• Create, format, edit, route, finalize, file, and maintain controlled documents within Thorne's Quality Management System.
• Maintain controlled documentation, including SOPs, work instructions, forms, specifications, formulas, master manufacturing records, policies, and other quality-related documents.
• Coordinate with SMEs and cross-functional stakeholders to ensure accuracy, completeness, and review of controlled documents.
• Ensure documentation progresses through established review, approval, and finalization processes.
• Coordinate periodic document reviews and ensure timely completion of reviews.

Skills

Attention to detail

Documentation

cGMP knowledge

GDP knowledge

ERP systems

Microsoft Word

Microsoft Excel

Batch records

QA mindset

Education

High school diploma or GED

Tools

ERP system

QMS software

MS Word

MS Excel

Job description

Thorne is seeking a Quality Assurance Document Control Specialist in Summerville, SC, to manage controlled documents, batch records, and change management within the QMS. The role emphasizes accuracy, data integrity, and regulatory compliance in a cGMP environment.

You will collaborate with Quality Assurance, Quality Control, and Manufacturing teams to ensure documentation is current, traceable, and ready for product disposition.