Quality Assurance & Document Control 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

Work Arrangement

Full-time, on-site

3V Sigma is a global producer of specialty chemicals with approximately 500 employees and four manufacturing facilities in the United States and northern Italy. Our Georgetown facility brings together manufacturing, quality, engineering, R&D, and operations teams to produce innovative, high-quality products for customers around the world.

Description Location: Georgetown, South Carolina Work Arrangement: Full-time, on-site 3V Sigma is a global producer of specialty chemicals with approximately 500 employees and four manufacturing facilities in the United States and northern Italy. Our Georgetown facility brings together manufacturing, quality, engineering, R&D, and operations teams to produce innovative, high-quality products for customers around the world. We are seeking a detail-oriented Quality Assurance & Document Control Specialist to support our quality systems and manufacturing operations. This position is responsible for maintaining controlled quality documents, reviewing production batch records, supporting quality investigations, and helping ensure compliance with ISO 9001:2015 and EFfCI requirements. This is a good opportunity for someone who enjoys detailed work, understands the importance of accurate manufacturing records, and is comfortable working across multiple departments to keep quality processes moving.

What You’ll Do

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

Requirements

• High school diploma or equivalent required.
• Previous experience in quality assurance, document control, quality systems, or a regulated manufacturing environment is preferred.
• An associate degree, technical training, or college coursework in quality, manufacturing, business, science, or a related field is helpful but not required.
• Familiarity with ISO 9001:2015, document-control practices, CAPA, MOC, deviations, or batch-record review is strongly preferred.
• Strong attention to detail and the ability to identify missing, inconsistent, or incomplete information.
• Strong organizational skills with the ability to manage multiple documents, deadlines, and priorities.
• Proficiency with Microsoft Word, Excel, Outlook, and PowerPoint.
• Clear written and verbal communication skills.
• Ability to work independently while also collaborating with employees across different departments.
• Sound judgment when handling controlled or confidential information.
• Experience writing or revising procedures and work instructions is a plus.

Right Fit

The right candidate will be organized, dependable, and comfortable following established processes while also looking for practical ways to improve them. You should be willing to ask questions, follow up when documentation is incomplete, and work directly with manufacturing and technical teams to help maintain consistent quality standards.