Quality Systems & Documentation Specialist

3V Sigma USA; Georgetown (SC); On-site; USD 42,000 - 64,000; Full time

Job summary

3V Sigma USA in Georgetown, SC is seeking a detail‑oriented Quality Assurance & Document Control Specialist to support quality systems and manufacturing operations. You will maintain controlled documents, review batch records, and help ensure ISO 9001:2015 and EFfCI compliance.

Responsibilities include issuing production batch sheets, supporting CAPA/MOC processes, and training staff on quality documentation.

Qualifications

• High school diploma or equivalent required.
• Experience in quality assurance, document control, or regulated manufacturing preferred.
• Familiarity with ISO 9001:2015, CAPA, MOC, deviations, or batch-record review is helpful.
• Strong attention to detail and ability to identify missing/incomplete information.
• Strong organizational skills with ability to manage multiple documents and deadlines.

Responsibilities

• Maintain, organize, file, and archive controlled quality documents and records.
• Review batch sheets for accuracy, completeness, approvals, and deviations.
• Issue and release production batch sheets, labels, and related docs.
• Support MOC, CAPA, and OOS processes.
• Assist investigations involving batch deviations or quality issues.
• Maintain Technical Data Sheets, calibration lists, procedures, and other documents.
• Write, revise, format, and route SOPs, work instructions, and forms.
• Track document revisions and ensure current versions are available to departments.
• Support internal audits and ISO 9001:2015 / EFfCI quality activities.
• Collaborate with Production, QC, R&D, Engineering to resolve documentation issues.
• Assist with employee training on quality procedures and documentation.
• Participate in corrective actions and continuous improvement initiatives.

Skills

Attention to detail

Organizational skills

Clear communication

Team collaboration

Education

High school diploma

Associate degree / coursework in quality or related field

Tools

Microsoft Word

Excel

Outlook

PowerPoint

Job description

3V Sigma USA in Georgetown, SC is seeking a detail‑oriented Quality Assurance & Document Control Specialist to support quality systems and manufacturing operations. You will maintain controlled documents, review batch records, and help ensure ISO 9001:2015 and EFfCI compliance.

Responsibilities include issuing production batch sheets, supporting CAPA/MOC processes, and training staff on quality documentation.