Principal Specialist – Quality Validation

Job not on LinkedIn

🔥 16 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🔴 Lead

👻 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

• Ensure the quality of IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting • Review and approve enterprise software validation lifecycle deliverables • Provide global oversight of enterprise software validation • Review and approve enterprise software change controls, CAPAs, and deviations • Support the global data integrity initiative • Provide strategic and technical expertise on global software validation matters • Ensure compliance with cGMPs, legal and regulatory requirements, and KBI internal requirements

🎯 Requirements

• BS and 8+ years’ experience or MS and 6+ years’ experience in a QA or GMP environment or equivalent • Experience in Data Integrity, computer system validation, and IT quality in an FDA regulated manufacturing environment • Demonstrated expert knowledge of 21 CFR Part 11 and/or EU Annex 11 • Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, and governmental regulations • Ability to write reports, business correspondence, and procedures • Ability to present information and respond to questions from staff, colleagues, managers, and clients • Ability to read, analyze, and author complex documentation • Ability to solve practical problems with limited standardization • Ability to interpret written, oral, diagram, or schedule-based instructions

🏖️ Benefits

• EEO/AA employer committed to workforce diversity • Approximately 10% domestic and international travel