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Quality And Compliance Specialist II / III
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- The Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status.
- They may also be responsible for conducting internal audits, participating in third-party audits, participating in and/or leading efforts towards site-preparedness/readiness for regulatory inspections.
- Lead and conduct internal quality audits in manufacturing, QC, facilities, warehouse, and utility areas according to established procedures, cGMP and company standards.
- Train auditors according to established procedures, cGMP and company standards.
- Review batch records, in-process documents, analytical data, and other documentation to ensure compliance with corresponding procedures, cGMP and company standards.
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