Overview
On Site
USD 50.00 - 55.00 per hour
Contract - W2
Skills
Recruiting
SAP BASIS
Quality Control
Regulatory Compliance
Assays
Test Methods
Auditing
Documentation
GMP
Media
Writing
Corrective And Preventive Action
LIMS
SAP
Microbiology
Biology
Biotechnology
Training
Quality Management
Good Manufacturing Practice
Data Integrity
Job Details
Our client is hiring a QC Microbiology Data Reviewer and Writer on a long-term contract basis.
Work Location: Indianapolis, IN
Work Model: On-Site
Summary:
Responsibilities:
Required Qualifications:
Pay Rate: $50 - $55
Job ID: 84025
Work Location: Indianapolis, IN
Work Model: On-Site
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, 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 the 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.
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 the 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.
Required Qualifications:
- 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.
- Bachelor's degree in Microbiology, Biology or Biotechnology or equivalent.
- Preferred training in Quality systems, cGMP, and Data Integrity.
Pay Rate: $50 - $55
Job ID: 84025
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