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Research Biologics Quality Assurance Auditor
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Full-time
- Overview The Quality Assurance (QA) Auditor provides compliance and quality improvement support to the manufacture of phase 1/2a Investigational New Drug, Biologics manufacture and facility operations.
- In addition to conducting activities that ensure the biologics manufacture and facility is compliant with applicable regulations, policies, procedures and expectations of phase appropriate current Good Manufacturing Practices (cGMP).
- The QA Auditor I will perform a variety of quality improvement and process improvement initiatives as requested by the Quality Assurance Manager.
- Here, Diversity, Equity and Inclusion are integrated into our core values and practices.
- Responsibilities PRINCIPAL DUTIES AND RESPONSIBILITIES Under the guidance and direction of the QA Manager, essential functions of the QA Auditor include: Operate within the Quality Management Systems applicable to Investigational New Drugs, and Good Tissue Practices.
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