QC Microbiology Data Reviewer and Writer
Job Number: 25-05746 Be 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. 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. • Bachelor's degree in Microbiology, Biology or Biotechnology or equivalent. • Preferred training in Quality Systems, cGMP, and Data Integrity. Pay Rate: $57 - $60 / Hour If hired, you will enjoy the following ECLARO Benefits: • 401k Retirement Savings Plan administered by Merrill Lynch • Commuter Check Pretax Commuter Benefits • Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact: Jane Bautista [email protected] 332-206-0772 Jane Bautista | LinkedIn Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws. Apply tot his job Apply tot his job