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