QC Microbiology Data Review - Indianapolis

Only for registered members Indianapolis, United States

3 weeks ago

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Job summary

Perform independent and thorough review of QC microbiology data for completeness accuracy and cGMP compliance Verify raw data calculations instrument outputs electronic records for assays including but not limited to bioburden sterility endotoxin media qualification environmental monitoring Confirm adherence to SOPs test methods approved protocols Ensure documentation meets ALCOA+ data integrity principles Identify discrepancies errors or atypical results work with analysts to resolve issues ensure right the first-time documentation Review EM results proper escalation out of trend excursions findings Write deviations CAPAs revise SOPs Write monthly quarterly reports environmental monitoring Support internal external audits providing clear compliant documentation


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