QA Documentation Specialist

Job Responsibilities:
• Manage and maintain controlled documents within the eQMS, including SOPs, work instructions, and batch records, ensuring accuracy, compliance, and proper approval routing
• Generate, review, and reconcile GxP documentation, supporting batch record accuracy and release processes
• Serve as a resource for document control processes, including document authoring, revisions, and workflow within quality systems
• Support QMS activities including audit readiness, internal audits, CAPA tracking, and quality metrics reporting
• Coordinate and align procedures across sites to ensure consistency and compliance with regulatory standards
• Assist in validation documentation (IQ/OQ/PQ) and ensure proper documentation practices are followed
• Provide general QA support, including submission review, document tracking, and cross-functional collaboration with operations

Qualifications:
• 5+ years of experience in Quality Assurance and document control within a regulated pharmaceutical or medical device environment
• Strong knowledge of FDA regulations, cGMP, and Good Documentation Practices (GDP)
• Experience with eQMS systems, document routing/approvals, and audit support
• Bachelor’s degree preferred (or equivalent experience)
• Strong organizational, technical writing, and communication skills with high attention to detail