Quality Systems & Documentation Specialist (On-Site)

3V Sigma USA Inc.; Georgetown (SC); On-site; USD 45,000 - 65,000; Full time

Job summary

3V Sigma USA Inc. in Georgetown, SC, is seeking a detail-oriented Quality Assurance & Document Control Specialist to support quality systems and manufacturing operations on-site.

The role involves maintaining controlled documents, reviewing batch records, supporting CAPA/MOC/OOS, and helping ensure ISO 9001:2015 and EFfCI compliance across Production, QC, R&D, and Engineering. Candidates should have solid documentation skills and the ability to work across departments to keep quality processes

Qualifications

• High school diploma or equivalent required.
• Experience in quality assurance, document control, or a regulated manufacturing environment preferred.
• Familiarity with ISO 9001:2015, CAPA, MOC, deviations, or batch-record review preferred.
• Strong attention to detail and ability to manage multiple documents and deadlines.
• Proficient with MS Word, Excel, Outlook, and PowerPoint; good written and verbal communication.
• Ability to work independently and with cross-functional teams.

Responsibilities

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

Skills

Attention to detail

Organizational skills

Communication skills

Education

High school diploma or equivalent

Associate degree or technical training in quality/manufacturing/science

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

PowerPoint

Job description

3V Sigma USA Inc. in Georgetown, SC, is seeking a detail-oriented Quality Assurance & Document Control Specialist to support quality systems and manufacturing operations on-site.

The role involves maintaining controlled documents, reviewing batch records, supporting CAPA/MOC/OOS, and helping ensure ISO 9001:2015 and EFfCI compliance across Production, QC, R&D, and Engineering. Candidates should have solid documentation skills and the ability to work across departments to keep quality processes