QC Microbiology Data Reviewer jobs in United States
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Net2Source (N2S) · 2 hours ago

QC Microbiology Data Reviewer

positionIndianapolis, IN
timeContract
remoteOnsite
seniorityMid Level
money$50/hr - $55.94/hr
date4+ years exp

Net2Source Inc. is an award-winning total workforce solutions company recognized for its rapid growth and extensive global operations. They are seeking a QC Microbiology Data Reviewer and Writer to perform thorough reviews of QC microbiology data, ensuring compliance with cGMP and data integrity principles, while also supporting audits and writing required documentation.

B2BDeliveryHuman ResourcesInformation Technology
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Kajal Singh, MBA
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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 data reviewBioburden testingEndotoxin testingEnvironmental MonitoringSOP writingLIMS experienceMS SharePointQuality systems trainingData Integrity trainingCAPA processes

Required

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
Bachelor's degree in microbiology, Biology or Biotechnology or equivalent

Preferred

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

Company

Net2Source (N2S)

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Net2Source (N2S) is a Minority owned global workforce solutions company recognized by SIA as the largest and fastest-growing Total Talent Solutions provider with a presence in 34 countries and in-house Glo-Cal (global and local) teams to support our clients.
dateFounded in 2007
location
Somerset, New Jersey, USA
people-size1001-5000 employees
web-link
http://net2source.com

H1B Sponsorship

Net2Source (N2S) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (7)
2022 (8)
2021 (10)
2020 (25)

Funding

Current Stage
Late Stage

Leadership Team

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Ashish Garg
Founder & CEO
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Company data provided by crunchbase