QC Microbiology Data Reviewer and Writer

Job Number: 25-05746Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a QC Microbiology Data Reviewer and Writer for our client in Indianapolis, IN.ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!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.

• 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.
• Bachelor's degree in Microbiology, Biology or Biotechnology or equivalent.
• Preferred training in Quality Systems, cGMP, and Data Integrity.

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO