IT Business Systems Analyst

Job not on LinkedIn

🔥 10 minutes ago

⛰️ Colorado, North Carolina – Remote

⛰️ Colorado – Remote 🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Business Analyst

👻 Ghost score 11%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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JSR Micro, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏭 Manufacturing

Semiconductor • Manufacturing • Technology

JSR Micro, Inc. is a leading supplier of high-performance semiconductor lithography materials. With over 30 years of excellence in manufacturing and innovation, JSR Micro focuses on developing advanced electronic materials, particularly for the semiconductor industry. The company recently expanded its capabilities by acquiring Yamanaka Hutech Corp. , a manufacturer of high-purity chemicals for semiconductors, which strengthens its market position and aligns with its growth strategy. JSR Micro is recognized for its commitment to sustainability and quality, as evidenced by its recent awards for outstanding performance in front-end quality.

📋 Description

• Lead requirements gathering, process mapping, and gap analysis for Quality Systems, including eQMS, CAPA, Deviations, Change Management, and Audit Management • Translate business and regulatory requirements into functional and technical specifications • Partner with Quality and business operations to design compliant and efficient system solutions • Ensure systems comply with GxP, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles • Support system validation activities, including validation planning, risk assessments, IQ/OQ/PQ, and change control • Act as a subject matter expert for Quality Systems during audits and inspections • Own or support system lifecycle activities, including implementation, upgrades, enhancements, and decommissioning • Identify opportunities for automation, standardization, and system integration • Evaluate vendor solutions and support system selection • Advise Quality leadership on system capabilities and roadmap planning • Lead cross-functional workshops and working groups • Mentor junior analysts and contribute to business analysis and validation best practices • Support data governance, reporting, and analytics for Quality metrics and KPIs • Manage complex, multi-region or multi-site Quality System initiatives • Operate autonomously with minimal supervision and resolve non-routine problems requiring judgment, regulatory knowledge, and stakeholder alignment

🎯 Requirements

• Bachelor’s degree in Information Systems, Engineering, Life Sciences, or related discipline • 6–10 years of experience in business systems analysis • At least 4–6 years supporting GxP-regulated Quality Systems in the pharmaceutical or biotechnology industry • Proven experience with eQMS platforms such as Veeva Vault QMS, TrackWise, or MasterControl • Strong background in system validation and regulated Software Development Lifecycle methodologies • Deep understanding of biopharmaceutical Quality processes and regulatory expectations • Strong analytical, documentation, and problem-solving skills • Ability to communicate complex technical and regulatory concepts to non-technical stakeholders • Experience working in global, matrixed organizations • Familiarity with FDA 21 CFR Part 11, Annex 11, and global regulatory expectations

🏖️ Benefits

• EEO/AA employer • Equal employment opportunity for qualified applicants regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status • At-will employment