Quality Assurance & Document Control Specialist
$41,600–$62,400 year
On-siteGeorgetown, South Carolina, United States
Job Summary
Maintain, organize, file, and archive controlled quality documents and records while reviewing completed batch sheets for accuracy, completeness, required approvals, and documented deviations. Issue and release production batch sheets, box labels, and supersack labels, and support Management of Change, Corrective and Preventive Action, and Out-of-Specification processes. Assist with investigations involving batch-record deviations, product complaints, and other quality-related issues, and maintain Technical Data 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, tracking revisions to ensure current, approved versions are available. Support internal audits related to ISO 9001:2015 and EFfCI requirements, work with Production, Quality Control, R&D, Engineering, and other departments to resolve documentation issues, and assist with employee training on quality procedures. Participate in corrective actions and continuous improvement initiatives to help ensure compliance with global standards.
Required Qualifications
- High school diploma or equivalent
- Bachelor's degree, associate degree, technical training, or college coursework in quality, manufacturing, business, science, or a related field
- 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
Desired Qualifications
- Previous experience in quality assurance, document control, quality systems, or a regulated manufacturing environment
- Familiarity with ISO 9001:2015, document-control practices, CAPA, MOC, deviations, or batch-record review
- 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
- Experience writing or revising procedures and work instructions
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