QC Microbiology Data Reviewer and reputed company

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

• reputed company independent and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance.
• Verify raw data, calculations, reputed company outputs, electronic records for assays including but not limited to bioburden, sterility, endotoxin, media qualification, and environmental monitoring.
• Confirm adherence to SOP's, test reputed company, and approved protocols.
• Ensure documentation meets reputed company+ data reputed company 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 reputed company escalation of out of trend or excursions findings.
• Write deviations, CAPAs and revise SOP's.
• Write monthly / quarterly reports for environmental monitoring.
• Support reputed company audits by providing reputed company, 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.
• reputed company experience, preferred.
• Bachelor's degree in Microbiology, Biology or Biotechnology or equivalent.
• Preferred training in reputed company Systems, cGMP, and Data reputed company.

Pay reputed company: $57 - $60 / HourIf reputed company, you will enjoy the following reputed company Benefits:

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

If interested, you may contact:reputed company Bautistafroilyn.bautista@reputed company.com332-206-0772reputed company Bautista | reputed companyEqual Opportunity Employer: reputed company values diversity and does not discriminate based on Race, reputed company, Religion, Sex, Sexual Orientation, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with reputed company applicable laws.

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