JSR Micro, Inc.

Quality Specialist

• 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

Principal Specialist – Quality Validation

Business Analyst

• 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

IT Business Systems Analyst

Full-stack Engineer

• Design, develop, configure, and support enterprise Quality applications such as eQMS, deviation/CAPA, change management, audits, and document management systems
• Apply software engineering standards, best practices, and architectural patterns for Quality systems
• Provide technical guidance and mentoring to junior engineers and cross-functional team members
• Evaluate and recommend approaches to improve Quality system performance and compliance
• Ensure systems and changes comply with GxP, FDA, EMA, ICH, and other global regulatory requirements
• Ensure data integrity, system security, and audit readiness across Quality applications
• Translate business and quality process requirements into scalable technical solutions
• Provide advanced troubleshooting and root cause analysis for system issues impacting Quality operations
• Lead continuous improvement initiatives to reduce manual processes, improve system reliability, and enhance user experience
• Lead disaster recovery planning and exercise execution, business continuity, and system lifecycle management planning
• Operate with a high degree of autonomy, influence technical direction, and serve as a subject matter expert for software engineering best practices

Principal Specialist – Quality Validation

IT Business Systems Analyst

Senior Quality Systems Software Architect