QC Microbiologist – Pharma (Onsite – Indianapolis, IN) jobs in United States
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Stage 4 Solutions · 1 day ago

QC Microbiologist – Pharma (Onsite – Indianapolis, IN)

positionIndianapolis, IN
timeFull-time
remoteOnsite
seniorityMid Level
money$52/hr - $55.94/hr
date4+ years exp

Stage 4 Solutions is seeking a QC Microbiologist for a global pharmaceutical client. The role involves performing independent reviews of QC microbiology data to ensure compliance with cGMP standards and supporting documentation for various assays.

AdvertisingConsultingManagement ConsultingMarketing
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Growth Opportunities

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

Qualification

GMP microbiology experienceCGMP compliance knowledgeLIMS experienceQuality systems trainingData Integrity knowledgeMS SharePointSAP experienceBachelor’s degree in microbiologyWriting deviationsCAPAs

Required

Minimum 4 years' experience in GMP microbiology laboratory data review
Knowledge of Experience in writing and supporting investigations, deviations, or CAPA processes and SOPs
Experience with Sherpa or other LIMS
Intermediate level MS SharePoint experience
Bachelor's degree in microbiology, Biology or Biotechnology or equivalent

Preferred

SAP experience preferred
Preferred training in Quality systems, cGMP, and Data Integrity

Benefits

Health benefits
401K

Company

Stage 4 Solutions

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Stage 4 Solutions is a management consulting firm that provides marketing solutions services.
dateFounded in 2001
location
Saratoga, California, USA
people-size51-200 employees
web-link
https://www.stage4solutions.com

Funding

Current Stage
Growth Stage

Leadership Team

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Niti Agrawal
CEO and Founder
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Recent News

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Niti Agrawal on LinkedIn: Please be extra careful about job scams. Please read our note below about…
2024-04-06
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