Mindlance
Quality - QC Microbiology Data Reviewer and Writer
Mindlance, Indianapolis, Indiana, us, 46262
Quality - QC Microbiology Data Reviewer and Writer
Job Title: QC Microbiology Data Reviewer and Writer
Hybrid/Onsite: Onsite
Site Location: Indianapolis, IN
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
Key Responsibilities
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, and environmental monitoring
Confirm adherence to SOP’s, test methods, and approved protocols
Ensure documentation meets ALCOA+ data integrity principles
Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation
Review EM results and ensure proper escalation of out of trend or excursions findings
Write deviations, CAPAs and revise SOP’s
Write monthly / quarterly reports for environmental monitoring
Support internal and external audits by providing clear, complaint documentation
Qualifications
Minimum 4 years’ experience in GMP microbiology laboratory data review
Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring
Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
Experience with Sherpa or other LIMS
Intermediate level MS SharePoint experience
SAP experience preferred
Education
Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent
Preferred training in Quality systems, cGMP, and Data Integrity
EEO “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
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Hybrid/Onsite: Onsite
Site Location: Indianapolis, IN
Work Schedule: Monday - Friday, Business Hours (Weekends and Holidays as needed)
Key Responsibilities
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, and environmental monitoring
Confirm adherence to SOP’s, test methods, and approved protocols
Ensure documentation meets ALCOA+ data integrity principles
Identify discrepancies, errors or atypical results and work with analysts to resolve issues and ensure right the first-time documentation
Review EM results and ensure proper escalation of out of trend or excursions findings
Write deviations, CAPAs and revise SOP’s
Write monthly / quarterly reports for environmental monitoring
Support internal and external audits by providing clear, complaint documentation
Qualifications
Minimum 4 years’ experience in GMP microbiology laboratory data review
Knowledge of Bioburden, Endotoxin, Sterility, Media qualification, and Environmental Monitoring
Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs.
Experience with Sherpa or other LIMS
Intermediate level MS SharePoint experience
SAP experience preferred
Education
Bachelor’s degree in microbiology , Biology or Biotechnology or equivalent
Preferred training in Quality systems, cGMP, and Data Integrity
EEO “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
#J-18808-Ljbffr