Pinnaql

Manager

• Serve as the primary point of contact for day-to-day issue resolution and escalation
• Communicate with company-assigned teams and client contacts through email, calls, and meetings
• Address real-time claim-level challenges and escalated issues
• Act as a subject matter expert to drive quality and performance integrity
• Support the Client Relationship Manager and third-party vendor as part of the service delivery team
• Coordinate client meetings and maintain agendas and meeting notes when required
• Participate in internal client calls with the company and vendor
• Provide vendor guidance regarding client communication, policies, and protocols
• Manage day-to-day issue resolution and escalate larger challenges according to established processes
• Use client data, performance results, and KPIs to monitor performance and drive proactive communication and KPI improvement
• Identify and understand client-level KPI outliers
• Support client satisfaction and retention
• Serve as a subject matter resource for client and company KPIs and leadership objectives
• Monitor the Daily Tracker for assigned clients
• Monitor action plan results and Red Flag Action Plans
• Partner with the Client Relationship Manager to drive client behavioral changes that improve performance
• Initiate At-Risk Accounts as appropriate
• Ensure client issues are addressed and resolved accurately and promptly
• Complete ticket assignments and initiate tickets for identified issues
• Create client policies as needed
• Identify innovative solutions and new revenue opportunities supporting clients’ goals

Revenue Cycle Service Manager

General

• Lead qualification of the autoclave in San Juan and associated water and Clean Steam Generation systems within the approved qualification boundary
• Review facility, design, commissioning, vendor, maintenance, calibration, operating, and prior qualification documentation
• Perform field assessments, walkdowns, and document reviews to confirm equipment and 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 including installation and utility verification, controls and alarm testing, cycle parameter testing, chamber distribution/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, indicators, sampling, laboratory support, safety requirements, and execution prerequisites
• Generate, route, execute, and finalize IQ/OQ protocols using company procedures and document control processes
• Document discrepancies, exceptions, and deviations; coordinate corrective actions and authorized retesting
• Assemble complete, inspection-ready qualification packages for review and approval
• Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
• Support review comment resolution and final approval of qualification deliverables
• Maintain weekly forecasts, deliverable trackers, and time records

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 existing SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents, including validation plans, requirements, specifications, risk assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, 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 system changes and releases through Change Control and ensure validation, procedural, training, data, and operational readiness activities are complete
• Review qualification documents and system records, confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and documentation needs
• Perform field walkdowns and document reviews
• Generate and route IQ/OQ protocols for approval
• Execute approved IQ/OQ protocols according to company procedures and Good Documentation Practices
• Document discrepancies, exceptions, and deviations and provide technical information for resolution
• Coordinate authorized retesting after corrective actions
• Assemble executed protocols and supporting evidence into complete review packages
• Generate and maintain Requirements Traceability Matrices
• Generate Qualification Summary Reports
• Support review comment resolution and final approvals
• Maintain weekly forecasts, deliverable trackers, and time records

Computer System Validation Specialist

• Provide risk-based validation services for Factorian, L7 ESP, and other GxP computerized systems
• Review intended use, GxP impact, architecture, supplier documentation, configuration, interfaces, data flows, infrastructure dependencies, and existing SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, supplier assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, roles and permissions, audit trails, electronic records and signatures, data integrity, interfaces, calculations, reports, time synchronization, backup and recovery, migration, security, and system administration
• Execute approved testing, capture objective evidence, manage incidents and deviations, coordinate corrective actions and retesting, and maintain requirements-to-test traceability
• Govern changes and releases through Change Control and verify validation, procedural, training, data, and operational readiness activities before release
• Review requirements, design documents, manuals, commissioning and calibration records, certificates, risks, and lifecycle documents for assigned systems or equipment
• Confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and required documentation
• Perform field walkdowns and readiness document reviews
• Generate and maintain IQ/OQ protocols, Requirements Traceability Matrices, and Qualification Summary Reports
• Execute approved IQ/OQ protocols according to company procedures and Good Documentation Practices
• Document discrepancies, exceptions, and deviations; provide technical information for resolution
• Coordinate authorized retesting after corrective actions
• Assemble executed protocols and evidence packages for review and approval
• Support comment resolution and final approval of qualification documentation
• Maintain weekly forecasts, deliverable trackers, and time records

• 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 existing SDLC evidence
• Define validation approaches and identify gaps
• Develop, revise, execute, and close lifecycle documents, including assessments, validation plans, specifications, risk assessments, supplier assessments, test protocols, traceability matrices, discrepancy records, summary reports, and release documentation
• Evaluate and test controls for access, 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
• Ensure changes and releases are governed through Change Control and required validation, procedural, training, data, and operational readiness activities are complete
• Review qualification documents and evidence for assigned systems or equipment
• Confirm qualification boundaries, prerequisites, test strategies, acceptance criteria, and documentation needs
• Perform field walkdowns and document reviews
• Generate, route, execute, and close IQ/OQ protocols
• Document discrepancies, exceptions, and deviations and provide technical information for resolution
• Coordinate authorized retesting after corrective actions
• Assemble executed protocols and supporting evidence into complete packages
• Generate and maintain Requirements Traceability Matrices and Qualification Summary Reports
• Support review comment resolution and final approvals
• Maintain weekly forecasts, deliverable trackers, and time records

Engineer

• Lead and execute manufacturing process characterization studies
• Perform process capability assessments and data analysis
• Conduct manufacturing line evaluations and performance assessments
• Support process optimization and continuous improvement initiatives
• Provide equipment startup, troubleshooting, and operational readiness support
• Lead root cause investigations and support implementation of corrective actions
• Develop and execute engineering studies supporting manufacturing objectives and process improvements
• Collaborate with Manufacturing, Operations, Engineering, Maintenance, and Quality teams
• Develop and execute IQ, OQ, and PQ protocols
• Support qualification of new and existing manufacturing equipment and systems
• Execute system verification and validation activities
• Lead process validation planning, execution, data analysis, and reporting
• Provide commissioning and qualification support
• Support the full validation lifecycle from planning and protocol development through execution, deviation resolution, and final report approval
• Manage protocol deviations, exceptions, and associated investigations
• Support change control assessments and implementation activities
• Develop validation summary reports and final project deliverables
• Author, revise, and support approval of GMP technical documentation, including SOPs, batch records, manufacturing instructions, process evaluation reports, process characterization and validation protocols and reports, equipment qualification documentation, system verification documentation, engineering study protocols and reports, risk assessments, technical assessments, change controls, and user requirements

Revenue Cycle Service Manager

Autoclave and Supporting Utility Qualification Specialist

Computer System Validation Specialist

Computer System Validation Specialist

Computer System Validation Specialist

Senior Process Engineer / CQV Validation Engineer