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BCforward · 4 weeks ago

QC Microbiologist-Data Reviewer and Writer

Indianapolis, IN

Contract

Onsite

Mid Level

$55.95/hr - $55.95/hr

4+ years exp

BCforward is a company seeking a QC Microbiology Data Reviewer and Writer. The role involves reviewing QC microbiology data for compliance and accuracy, ensuring documentation integrity, and supporting audits by providing compliant documentation.

Information TechnologyRecruiting

H1B Sponsor Likely

Hiring Manager

Surya Jay

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 SOPs, 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 SOPs

Write monthly / quarterly reports for environmental monitoring

Support internal and external audits by providing clear, complaint documentation

Qualification

GMP microbiology experienceBioburden knowledgeEndotoxin knowledgeSterility knowledgeLIMS experienceMS SharePointSAP experienceWriting investigationsQuality systems trainingData Integrity training

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

Bachelors degree in microbiology, Biology or Biotechnology or equivalent

Preferred

SAP experience preferred

Preferred training in Quality systems, cGMP, and Data Integrity

Company

BCforward

Glassdoor3.2

BCforward is an information technology consulting and staffing firm.

Founded in 1998

Indianapolis, Indiana, USA

5001-10000 employees

https://www.bcforward.com

H1B Sponsorship

BCforward 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 (8)

2023 (8)

2022 (6)

2021 (6)

2020 (1)