Quality Assurance & Document Control Specialist
About The Position
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.
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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
