TSR Consulting
QC Microbiology Data Reviewer and Writer
Location: Indianapolis, IN.
Pay: $55.00–$56.00 per hour (W2).
Employment type: Contract (12+ months).
Seniority level: Associate.
Job function: Other. Industries: Pharmaceutical Manufacturing.
Base pay range: $55.00/hr – $56.00/hr.
(Please note local candidates only: Indianapolis IN ZIP 84025.)
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical company, is hiring for this role.
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 SOPs, 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-first-time documentation.
Review EM results and ensure proper escalation of out-of-trend or excursions findings.
Write deviations, CAPAs and revise SOPs.
Write monthly/quarterly reports for environmental monitoring.
Support internal and external audits by providing clear, compliant documentation.
Qualifications
Minimum 4 years’ experience in GMP microbiology laboratory data review.
Experience with CAPA and deviations.
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.
SAP experience preferred.
Bachelor’s degree in microbiology, biology or biotechnology or equivalent.
Preferred training in Quality systems, cGMP, and Data Integrity.
Benefits (inferred) Medical insurance.
401(k).
Referrals increase your chances of interviewing at TSR Consulting by 2x.
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Pay: $55.00–$56.00 per hour (W2).
Employment type: Contract (12+ months).
Seniority level: Associate.
Job function: Other. Industries: Pharmaceutical Manufacturing.
Base pay range: $55.00/hr – $56.00/hr.
(Please note local candidates only: Indianapolis IN ZIP 84025.)
TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical company, is hiring for this role.
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 SOPs, 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-first-time documentation.
Review EM results and ensure proper escalation of out-of-trend or excursions findings.
Write deviations, CAPAs and revise SOPs.
Write monthly/quarterly reports for environmental monitoring.
Support internal and external audits by providing clear, compliant documentation.
Qualifications
Minimum 4 years’ experience in GMP microbiology laboratory data review.
Experience with CAPA and deviations.
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.
SAP experience preferred.
Bachelor’s degree in microbiology, biology or biotechnology or equivalent.
Preferred training in Quality systems, cGMP, and Data Integrity.
Benefits (inferred) Medical insurance.
401(k).
Referrals increase your chances of interviewing at TSR Consulting by 2x.
#J-18808-Ljbffr