Kevin Moreno

Actively ensuring compliance with Validation Master Plan and Calibration Program, adhering to regulatory requirements, and upholding site policies.

• Proficient in managing projects within revalidation and environmental monitoring domains.
• Project management for revalidation programs including warehouse areas, establishment of temperature ranges and dirty hold studies.
• Lead project management for revalidation programs and Environmental Monitoring Process Qualification (EMPQ), optimizing operations and ensuring process efficiency.
• Author and execute validation protocols and technical reports, driving project planning and decision-making processes.
• Conduct quality impact assessments and participate in investigation teams, identifying and resolving issues through analytical skills.
• Maintain validated state of equipment and processes, ensuring regulatory compliance and operational efficiency.
• Coordinate validation and calibration activities for clinical product manufacturing, aligning with project timelines.
• Lead and manage comprehensive validation projects for computerized systems, overseeing GMP documentation and coordinating staff training in compliance procedures to ensure rigorous adherence to industry standards.
• Perform temperature mapping and GMP system impact assessments, integrating technical expertise with project management skills.
• Collaborate with quality assurance department for vendor onboarding and qualification, enhancing supply chain efficiency.
• Develop and implement maintenance plan using SAP, focusing on systems analysis and continuous improvement.
• Lead continuous improvement programs as Continuous Improvement Implantation Leader, achieving yearly goals of 50% and driving cost savings of over 100k through business improvement projects.
• Collaborate with cross-functional teams for identification and resolution of validation issues.
• Work with stakeholders and team members on implementing and establishing software, equipment, and building validation related functions.

Detail-oriented and analytical professional with extensive experience in quality control and environmental monitoring within Phase I/II multi-product biologic facility. Skilled in developing SOPs, managing quality assurance processes, and leading key projects in lab management system optimization and cost reduction.

• Develop and standardize standard operating (SOPs), on job training (OJT) materials, aligning with QC and QA regulatory standards.
• Manage equipment maintenance and usage in compliance with SOPs and safety policies.
• Act as key resource for software requirements in lab management systems and EM testing.
• Analyze and report EM and QC data to support production environment decision-making.
• Collaborate with system owners for QA, resolving performance issues effectively.
• Design and implement QC department training programs for environmental monitoring.
• Train manufacturing and QA teams on EM program requirements.
• Develop and manage PQ schedules, ensuring project adherence and completion.
• Validate software protocols for lab management systems, enhancing operational efficiency.
• Maintain quality standards, ensuring QC processes surpass industry benchmarks.
• Lead projects to commission lab management software and gas sampling systems, reducing testing costs and preparing for commercial production.
• Author protocols for validation and data integrity compliance.
• Represent company in software installation qualification for gas testing.
• Commission critical equipment, including SAS Super 180/100, Pinocchio Super II, TruScan RM Analyzer, and Agilent 990 Micro Gas Chromatograph.
• Collaborated with management to provide training on improved processes and implementation, creation, and maintenance of quality training program for cleanroom spaces within new facility.

Efficiently support microbiology and environmental monitoring testing programs, focusing on timely completion of testing and meticulous documentation. Adhere to standard operating procedures, emphasizing process optimization and commercialization readiness in biological facility.

• Conduct routine environmental, water, and gas sampling, ensuring strict adherence to protocols and quality standards.
• Perform critical water testing (pH, conductivity, endotoxin, TOC) following established procedures, demonstrating technical accuracy.
• Execute GMP test article testing (pH, Conductivity, Osmolality, A280, Endotoxin), maintaining compliance with industry standards.
• Lead method validation for A280 and conductivity tests, focusing on precision and accuracy.
• Manage QC data within validation protocols, ensuring accurate recording in lab management systems and maintaining audit trails.
• Train team members in environmental monitoring procedures and test methods, showcasing leadership and knowledge-sharing skills.
• Drive process improvements by initiating and revising standard operating procedures, reflecting strong analytical and project management capabilities.

Skilled Environmental Monitoring Specialist with expertise in routine monitoring within cleanroom manufacturing labs, adhering to standard operating procedures. Proficient in integrating environmental monitoring with advanced technology and bioscience lab requirements.

• Collaborated with internal teams to implement aseptic process simulations and qualify environmental monitoring processes, focusing on technology integration in bioscience labs.
• Enforced safe work practices and protocol compliance, contributing to culture of safety and adherence.
• Designed job structures for new recruits and generate trend reports using software management systems, enhancing data analysis and reporting capabilities.
• Oversaw regulatory and safety compliance, actively participating in internal investigations to resolve discrepancies.
• Managed calibration and maintenance of environmental monitoring equipment, ensuring optimal performance and compliance.
• Lead in preparation and execution of software management system validation protocols, demonstrating project management skills.
• Conducted data validation and report generation for room qualifications and software upgrades, showcasing analytical proficiency.
• Handled inventory management, data entry, and SOP revisions, reflecting strong organizational and multitasking skills.
• Established and implemented corrective and preventative actions (CAPA) training for handover error reduction.