Quality Assurance & Document Control Specialist

About the role

This position supports our quality systems and manufacturing operations at the Georgetown facility.

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.
• Absorb 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.
• Absorb employee training on quality procedures and documentation requirements after gaining the necessary experience.
• Participate in corrective actions and continuous improvement initiatives.

Requirements

• A 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.