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QA Specialist
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- In this role, you will be responsible for compliance to Issue Review (IR), Complaint Handling, and Corrective and Preventative Action (CAPA) processes and requirements by serving as a subject matter expert and providing guidance to IR, Complaint, CAPA owners and working closely with all areas in the development of IR, Complaint, CAPA activities and the rigorous assessment of CAPA documentation.
- Provide continuous and extensive assessment of all IR, Complaints, CAPA activities and documentation to ensure compliance with business practices, regulations, and ISO standards.
- Support the implementation of standardized procedures and systems for IRs, Complaints, and CAPA.
- Deliver metrics for IRs, Complaints, and CAPA to include weekly management tracking reports.
- Ensuring users provide consistency to the IRs, Complaints, and CAPA system content.
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