QC Microbiology Data Reviewer and Writer jobs in United States
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TSR Consulting · 2 weeks ago

QC Microbiology Data Reviewer and Writer

positionIndianapolis, IN
timeContract
remoteOnsite
seniorityMid Level
money$55/hr - $56/hr
date4+ years exp

TSR Consulting is a premier National U.S. Staffing company, and they are seeking a QC Microbiology Data Reviewer and Writer for a contracting assignment with a leading pharmaceutical company. The role involves reviewing QC microbiology data for compliance, accuracy, and completeness, as well as writing deviations and supporting audits.

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H1B Sponsor Likelynote

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 experienceBioburden knowledgeEndotoxin knowledgeCAPA experienceLIMS experienceMS SharePointSAP experienceSOP writingQuality systems trainingCGMP trainingData Integrity trainingBachelor’s degree

Required

Minimum 4 years' experience in GMP microbiology laboratory data review
Experience with CAPA and deviations
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

TSR Consulting

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TSR is a relationship-based, customer-focused IT and technical services staffing company.
dateFounded in 1969
location
Hauppauge, New York, USA
people-size501-1000 employees
web-link
http://www.tsrconsulting.com/

H1B Sponsorship

TSR Consulting 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 (4)
2024 (1)
2023 (3)
2022 (6)
2021 (1)
2020 (7)

Funding

Current Stage
Public Company
Total Funding
unknown
2012-08-20IPO

Leadership Team

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Thomas Salerno
CEO
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Company data provided by crunchbase