General

• Provide support to LUMA customers interested in applying for a rebate or seeking information or assistance on submitted applications, primarily through email and as needed by phone
• Process program applications accurately and efficiently, including reviewing applications and supporting documentation, entering information into the program tracking system, and following established procedures
• Maintain data accuracy and established program processes and procedures
• Identify and escalate issues affecting application processing, customer experience, or program performance
• Communicate and coordinate with other departments to support customer needs and ensure timely, accurate application processing
• Maintain electronic and hard-copy filing systems and application and rebate documentation while safeguarding confidential customer information
• Collaborate with team members on process improvements and continuous improvement efforts
• Provide peer training and job-shadowing support as assigned
• Perform other duties as assigned

Solution Delivery Coordinator – Business

• Lead qualification of the autoclave located in San Juan and associated water and Clean Steam Generation systems
• Review facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation
• Perform field assessments and walkdowns; confirm equipment, utility boundaries, interfaces, prerequisites, and readiness
• Develop or revise lifecycle documents, including URS, risk assessments, Validation Plans, IQ/OQ/PQ protocols, data sheets, RTMs, discrepancy/deviation records, and summary reports
• Define and execute qualification activities such as installation and utility verification, controls and alarm testing, cycle parameter testing, chamber distribution or mapping, load penetration studies, challenge testing, reproducibility, and acceptance criteria
• Verify or qualify supporting water and Clean Steam Generation systems, including generation, distribution, quality attributes, sampling, monitoring, controls, alarms, and interfaces
• Coordinate equipment availability, approved loads, calibrated instruments, biological or chemical indicators, sampling, laboratory support, safety requirements, and execution prerequisites
• Generate IQ/OQ protocols using Company procedures, templates, and document control processes; route protocols through approval
• Execute approved protocols according to Company procedures and Good Documentation Practices
• Document discrepancies, exceptions, and deviations; support assessment, corrective actions, resolution, and authorized retesting
• Assemble complete, inspection-ready qualification packages
• Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
• Support review comment resolution and final approval of qualification documents
• Maintain weekly forecasts, deliverable trackers, and time records
• Perform protocol execution and field activities on site in San Juan; document development may be remote when authorized

Autoclave and Supporting Utility Qualification Specialist

• Provide risk-based validation services for Factorian, L7 ESP, and other GxP computerized systems
• Review intended use, GxP impact, system architecture, supplier documentation, configuration, customization, interfaces, data flows, infrastructure dependencies, and SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, roles, permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, migration, security, and administration
• Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain traceability through closure
• Govern changes and releases through Change Control and confirm validation, procedural, training, data, and operational readiness before release
• Review qualification documents and supporting records
• Confirm qualification boundaries, components, prerequisites, test strategy, acceptance criteria, and documentation requirements
• Perform field walkdowns and document reviews
• Generate, route, execute, and close IQ/OQ protocols
• Document discrepancies, exceptions, and deviations and support resolution
• Assemble executed protocols and evidence packages
• Generate Requirements Traceability Matrices and Qualification Summary Reports
• Support review comment resolution and final approvals
• Maintain weekly forecasts, deliverable trackers, and time records

Computer System Validation Specialist

• Code and program enhancements, updates, and changes for portions and subsystems of systems software
• Execute established test plans and protocols; identify, log, and debug assigned issues
• Develop understanding of and relationships with internal and outsourced development partners
• Participate on project teams to develop reliable, cost-effective, high-quality solutions for low- to moderately-complex products

Software Intern

• Code and program enhancements, updates, and changes for portions and subsystems of systems software
• Execute established test plans and protocols
• Identify, log, and debug assigned issues
• Develop understanding of and relationships with internal and outsourced development partners
• Participate on project teams to develop reliable, cost-effective, high-quality solutions for low- to moderately-complex products

• Perform customer service and support the State Licensing department on day-to-day duties
• Draft online and hard copy state pharmaceutical applications
• Verify licenses
• Review signed applications for accuracy and completion
• Review outgoing and incoming physical mail, electronically if working remote
• Address deficiencies highlighted by the Board on behalf of customers
• Update the internal database to reflect application progression
• Maintain a document repository of customer supporting documents, applications, and deficiency correspondence
• Perform administrative work

Pharmaceutical Licensing Application Specialist

• Drive meaningful patient impact by leveraging scientific expertise and serving as the primary contact for customers in the assigned territory
• Collaborate with Account Executives, Integrated Delivery Systems leaders, and field colleagues as part of the local Customer Team
• Develop and manage relationships with cardiologists, primary care providers, and other healthcare professionals
• Engage with physicians’ offices, integrated delivery systems, pharmacies, and hospital clinics
• Develop and execute a territory-level business plan aligned with company policies, standards, and ethics
• Maintain current product knowledge and certifications for the company’s portfolio
• Conduct balanced and compliant product sales discussions with healthcare providers and business professionals
• Provide management with updates on customer needs, marketplace dynamics, and progress toward quality goals
• Stay knowledgeable about headquarters-approved information on company products, disease, and marketplace
• Monitor business performance against objectives using company tools
• Support the Cape Girardeau, MO territory covering Cape Girardeau, Farmington, Sikeston, Poplar Bluff, Jackson, and Festus
• Travel as needed, including approximately 25% overnight travel for client meetings and territory coverage

Cardiovascular Disease Specialist

• Drive patient impact by leveraging scientific expertise and serving as the primary customer contact within the assigned territory
• Collaborate with Account Executives, Integrated Delivery Systems leaders, and field colleagues as part of the local Customer Team
• Cover the Northeast PA District and other potential markets in the area
• Travel to client meetings and support comprehensive territory coverage; overnight travel may be required about 25% of the time
• Develop and manage relationships with cardiologists, primary care providers, and other healthcare professionals
• Engage with physicians’ offices, integrated delivery systems, pharmacies, and hospital clinics
• Develop and execute a territory-level business plan aligned with company policies, standards, and ethics
• Maintain current product knowledge and certifications for the company’s portfolio
• Conduct balanced and compliant product sales discussions according to product labeling
• Provide management with updates on customer needs, marketplace dynamics, and progress toward quality goals
• Maintain knowledge of headquarters-approved information regarding products, disease, and marketplace
• Monitor business performance against objectives using company tools