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Quality Assurance Specialist
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- This position will report to the Quality Assurance Manager.
- S/he represents Quality within cross-functional teams to coordinate documentation and ensure compliance for instrument IQ/OQ, assay Verification/Validation activities and Risk Management.
- Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.
- Conduct and support complaint handling activities such as intake, evaluation, investigations and reporting.
- Performs external vendor audits to ensure ISO and/or FDA compliance.
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