QC Systems Validation Associate jobs in United States
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Global Compliance Partners · 9 hours ago

QC Systems Validation Associate

positionRedmond, WA
timeFull-time
remoteOnsite
seniorityEntry, Mid Level
date1+ years exp

Global Compliance Partners is seeking a Junior/Mid-level QC Validation Engineer with hands on experience in QC systems validation to support a client site in Redmond, Washington. This role supports validation and compliance activities for laboratory and quality control computerized systems in a GMP environment.

AdviceInformation ServicesManagement ConsultingRisk Management
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H1B Sponsor Likelynote
Hiring Manager
Apurva Shah
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Responsibilities

Support Computer System Validation activities for QC laboratory systems including LIMS, CDS, ELN, standalone instruments, and supporting applications
Execute validation deliverables including URS review, risk assessments, validation protocols, test execution, and reports
Support system lifecycle documentation in accordance with GxP, FDA, and data integrity expectations
Assist with deviation investigations, impact assessments, and CAPA support related to validated systems
Support periodic reviews, change control assessments, and system release activities
Work closely with QC, QA, IT, and vendors to ensure compliant system implementation and maintenance
Maintain organized, inspection ready documentation

Qualification

QC systems validationGMP environment experienceFDA 21 CFR Part 11LIMS systemsDocumentation skillsCSA principlesAudit supportAttention to detail

Required

Bachelor's degree in Engineering, Life Sciences, or related field
1 to 3 years of experience in QC systems validation or CSV in a regulated GMP environment
Experience supporting QC laboratory systems preferred
Working knowledge of FDA 21 CFR Part 11 and data integrity principles
Strong documentation skills and attention to detail
Ability to work on site in Redmond, WA

Preferred

Experience with LIMS systems
Exposure to CSA principles
Prior experience supporting inspections or audits

Company

Global Compliance Partners

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Global Compliance Partners offers GCP consulting and management services for the biotech and pharmaceutical sectors.
dateFounded in 2015
location
Seattle, Washington, USA
people-size11-50 employees
web-link
https://globalcompliancepartners.com

H1B Sponsorship

Global Compliance Partners 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 (1)

Funding

Current Stage
Early Stage
Company data provided by crunchbase