Job Description
Job Title: QA Associate
Job Description
The Quality Assurance (QA) Associate supports clinical and commercial manufacturing operations by reviewing and managing documentation for registration and clinical batches. This role ensures compliance with FDA and other regulatory requirements, supports R&D and feasibility projects, and contributes to continuous improvement in quality and compliance. The QA Associate works independently on smaller projects, collaborates closely with cross-functional teams, and maintains high standards of accuracy, accountability, and attention to detail.
Responsibilities
+ Review and interpret batch records, manufacturing protocols, and registration/clinical batch documentation to ensure completeness, accuracy, and compliance.
+ Verify that all documentation aligns with FDA regulations and other applicable regulatory agency requirements.
+ Review and manage deviations, change controls, and CAPAs, ensuring they are properly do...
Job Description
The Quality Assurance (QA) Associate supports clinical and commercial manufacturing operations by reviewing and managing documentation for registration and clinical batches. This role ensures compliance with FDA and other regulatory requirements, supports R&D and feasibility projects, and contributes to continuous improvement in quality and compliance. The QA Associate works independently on smaller projects, collaborates closely with cross-functional teams, and maintains high standards of accuracy, accountability, and attention to detail.
Responsibilities
+ Review and interpret batch records, manufacturing protocols, and registration/clinical batch documentation to ensure completeness, accuracy, and compliance.
+ Verify that all documentation aligns with FDA regulations and other applicable regulatory agency requirements.
+ Review and manage deviations, change controls, and CAPAs, ensuring they are properly do...