What are the responsibilities and job description for the QC Microbiology Data Reviewer and Writer position at Integrated Resources, Inc?
Job Title: QC Microbiology Data Reviewer and WriterJob Location: Indianapolis, INDuration: 12 MonthsWork Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)Key ResponsibilitiesPerform independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP complianceVerify raw data, calculations, instrument outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoringConfirm adherence to SOP’s, test methods, and approved protocolsEnsure documentation meets ALCOA data integrity principlesIdentify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentationReview EM results and ensure proper escalation of out of trend or excursions findingsWrite deviations, CAPAs and revise SOP’sWrite monthly / quarterly reports for environmental monitoringSupport internal and external audits by providing clear, complaint documentationQualificationsMinimum 4 years’ experience in GMP microbiology laboratory data reviewKnowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental MonitoringExperience in writing and supporting investigations, deviations, or CAPA processes and SOPs.Experience with Sherpa or other LIMSIntermediate level MS SharePoint experienceSAP experience preferredEducation:Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent,Preferred training in Quality systems, cGMP, and Data Integrity,#sczr2
Salary : $55,000 - $68,000