QA Documentation Specialist
Harba Solutions Limited, Fishers, IN, United States
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
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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
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