GMP Tester jobs in United States
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BluFeather Solutions · 7 hours ago

GMP Tester

positionUnited States
timeContract
remoteRemote
senioritySenior Level
money$50/hr - $60/hr
date5+ years exp

BluFeather Solutions is a company focused on providing solutions in the pharmaceutical and biotech sectors. They are seeking a GMP Tester to design and execute validation testing for GMP systems, ensuring compliance with GMP/GxP/CSV standards and supporting audits with complete documentation.

Information Technology & Services
Hiring Manager
Bill Martin
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Responsibilities

Design & execute validation testing for GMP systems (IQ/OQ/PQ, UAT)
Review/maintain traceability matrices; ensure full requirements coverage
Validate MES, LIMS, ArchestrA, DCS/InBatch, Veeva and related lab/manufacturing apps
Ensure compliance with GMP/GxP/CSV and support audits/inspections with complete documentation
Drive defect management, RCA and CAPA, collaborate with QA/IT/manufacturing

Qualification

GMP validationIQ/OQ/PQ testingLIMS/MES/ArchestrAGMP/GxP/CSV complianceDocumentation skillsStakeholder communicationAgile familiarityDB basicsSplunk/ServiceNowUiPath exposure

Required

5+ years in pharma/biotech GMP validation (regulated environments)
Hands-on with IQ/OQ/PQ, UAT, protocol authoring/execution, deviations
Experience with LIMS/MES/ArchestrA/DCS/Veeva, traceability, data integrity (ALCOA+)
Strong documentation, stakeholder comms; Agile familiarity

Preferred

DB basics (Oracle/SQL Server)
Splunk/ServiceNow
UiPath exposure

Company

BluFeather Solutions

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BluFeather Solutions empowers organizations to streamline their AI/Gen AI/ML journey
dateFounded in 2022
location
Fremont, California, US
people-size51-200 employees
web-link
https://www.blufeathersolution.com/

Funding

Current Stage
Growth Stage
Company data provided by crunchbase