CSA Auditor, TraceLink jobs in United States
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I.T. Solutions, Inc. · 2 months ago

CSA Auditor, TraceLink

positionUnited States
timeFull-time
remoteRemote
senioritySenior Level
money$90/hr - $100/hr
date5+ years exp

I.T. Solutions, Inc. is seeking a Computerized System Assurance (CSA) Auditor with expertise in TraceLink and GxP-regulated environments. The role involves ensuring compliance and validation of computerized systems, conducting audits, and collaborating with various departments to address compliance gaps.

ConsultingInformation TechnologyOutsourcingProject ManagementSoftware
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Plan, conduct, and report CSA audits of TraceLink implementations, integrations, and supporting systems across global sites and third-party vendors
Evaluate system lifecycle documentation—including validation plans, risk assessments, IQ/OQ/PQ reports, user requirements, and traceability matrices
Ensure TraceLink environments (Track & Trace, Serialization, Compliance Reporting, etc.) align with 21 CFR Part 11, Annex 11, GAMP 5, and internal quality standards
Collaborate with IT, QA, Supply Chain, and vendors to identify and remediate compliance gaps
Assess change control, incident management, and periodic review processes for TraceLink and related systems
Provide expertise in CSA methodology—focusing on risk-based validation, automation, and efficiency improvements over traditional CSV approaches
Author and maintain audit reports, CAPAs, and follow-up documentation
Support internal training and continuous improvement in system assurance best practices

Qualification

TraceLinkGxP computer system validationFDA 21 CFR Part 11Audit preparationExecutionData integrity principlesAgile methodologiesITIL methodologiesSDLC methodologiesRelevant certificationsDocumentation skillsCommunication skills

Required

Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field
5+ years of experience in GxP computer system validation (CSV/CSA), including vendor and system audits
2+ years of hands-on experience with TraceLink (serialization, compliance reporting, or integration modules)
Strong knowledge of FDA 21 CFR Part 11, Annex 11, GAMP 5, and data integrity principles
Experience with audit preparation, execution, and CAPA follow-up
Excellent documentation and communication skills

Preferred

Experience with pharmaceutical supply chain systems and serialization compliance
Prior experience auditing SaaS/cloud-based systems
Understanding of Agile, ITIL, or SDLC methodologies in regulated contexts
Relevant certifications (e.g., ASQ CQA, ISPE GAMP, RAPS, or equivalent)

Benefits

Comprehensive and highly competitive benefits package

Company

I.T. Solutions, Inc.

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itsoli is a Consulting and Professional Services firm that provides the in-depth expertise your business needs and the flexibility your changing environment requires to help you succeed.
dateFounded in 2004
location
San Mateo, California, USA
people-size201-500 employees
web-link
https://www.itsoli.com/

H1B Sponsorship

I.T. Solutions, Inc. 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 (18)
2024 (19)
2023 (19)
2022 (22)
2021 (8)
2020 (8)

Funding

Current Stage
Growth Stage

Leadership Team

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Tina Khouri
Partner
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Company data provided by crunchbase