Alma Lastrella

• Managed the build-out and daily operations of a high-complexity CLIA/CAP-accredited molecular diagnostics laboratory specializing in Optical Genome Mapping (OGM) testing.
• Oversaw regulatory compliance, quality systems, client onboarding, billing and reimbursement workflows, vendor qualification and audits, inventory and supply chain management, and performance management of laboratory personnel.
• Maintained full accountability for the department’s annual operating budget, cost controls, and resource planning while maintaining continuous inspection readiness and operational scalability.
• Established a fully operational CLIA/CAP laboratory from concept to inspection, achieving zero deficiencies on first submission.
• Directed end-to-end validation and clinical implementation of multiple OGM LDTs (FSHD, HEME, Constitutional Postnatal/Prenatal).
• Designed and implemented a comprehensive Quality Management System (QMS), including SOPs, document control, CAPA, change control, and MediaLab document management system validation and documents migration.
• Executed IQ/OQ/PQ for instruments and reagent qualifications; strengthened equipment lifecycle management.
• Managed the end-to-end relocation and consolidation of the Lineagen laboratory from Salt Lake City to San Diego without disruption to clinical services.
• Implemented KPI dashboards and quality metrics to monitor performance, deviations, complaints and CAPA effectiveness.
• Elevated team performance through structured training, competency assessments, and workflow redesigns.

• Supervised high-throughput COVID-19 testing operations during the peak of the pandemic, leading 25 laboratory personnel across testing and non-testing functions to ensure timely, accurate, and compliant patient results.
• Improved turnaround time through workflow optimization and bench layout redesign.
• Authored and implemented technical SOPs, validation plans, and equipment qualification documentation.
• Led vendor audits, safety inspections, and CLIA/CAP inspection readiness activities.
• Collaborated with R&D teams on COVID-19 research projects published in scientific journals.
• Strengthened quality control through monthly equipment audits and QC record reviews.
• Performed data analysis, result review, and final sign-out of COVID-19 test cases to ensure accuracy and regulatory compliance.

• Managed the complete startup of a new CLIA-certified laboratory, overseeing laboratory build-out, equipment installation and validation, workflow development, staff readiness, and operational integration of quality and regulatory systems.
• Successfully secured CLIA certification by designing policies, procedures, and validation protocols.
• Implemented QMS aligned with CLSI standards, CAP checklists, and CLIA requirements.
• Validated equipment, reagents, and materials in support of LDT development.
• Collaborated with R&D on design control and test method development for clinical assay validation.
• Enhanced operational efficiency by identifying workflow bottlenecks and recommending improvements.

• Managed daily laboratory operations for NGS and cytogenetic workflows supporting single-cell cancer diagnostics.
• Supervised testing activities, reagent and supply management, documentation, and quality control while ensuring continuous CLIA/CAP compliance and efficient turnaround of clinical results.
• Successfully led the laboratory through CLIA and CAP inspections with zero deficiencies.
• Streamlined reagent and antibody inventory management, reducing waste and improving turnaround time.
• Created and implemented new batch records, SOPs, and workflow improvements to increase efficiency and consistency.
• Supported LIMS system validation and cross-functional project execution, improving data integrity and operational coordination.

• Directed operations for molecular NIPT testing, including pre-analytical, analytical, and post-analytical workflows.
• Performed high-complexity molecular testing—including DNA isolation, library preparation, sequencing, data analysis, and QC while overseeing workflow, production, and timely reporting of patient results.
• Managed sample logistics, accessioning, and processing, and provided training, competency assessments, and annual performance reviews of laboratory personnel.
• Improved staff productivity by 90% through cross-training, streamlined workflows, and resource realignment into two-shift schedule.
• Developed productivity and quality metrics used for monthly QMS reporting.
• Executed validation plans for software upgrades and MaterniT21 assay enhancements.
• Reduced costs through improved inventory management and supply optimization.
• Maintained full regulatory compliance, supporting successful CLIA/CAP accreditation.
• Promoted to Senior Manager, Laboratory Operations within one year due to strong performance.

• Oversaw technical testing operations, data review, and reporting for LC-MS/MS assays supporting drug identification and quantification.
• Led process improvements in quality, safety, document control, QC, and proficiency testing.
• Troubleshot instrument and assay performance issues and conducted internal audits, gap analyses, and competency assessments to support CLIA, CAP, and NYS inspection readiness.
• Strengthened quality and compliance through targeted audits, documentation improvements, and SOP revisions.
• Enhanced workflow accuracy and efficiency by resolving instruments and testing performance issues.
• Fostered collaboration among team members to improve productivity and support a positive work environment.

• Directed daily laboratory operations across Molecular Genetics, Chemistry, Oncology, and Immunology, ensuring accuracy, quality control, equipment readiness, and regulatory compliance under CLIA, CAP, ISO, and FDA requirements.
• Managed budgets, staffing, equipment programs, CAPA investigations, deviations, and quality systems.
• Partnered with leadership on process-improvement initiatives to enhance efficiency and regulatory readiness.
• Led equipment and process validations for new test systems and software upgrades.
• Developed proficiency testing, competency assessment, and comprehensive training programs.
• Executed a major sample integrity project supporting IBS/IBD testing workflows.
• Produced monthly KPI and quality reports to guide operational and quality decisions.
• Implemented Kanban inventory system, reducing supply waste and improving replenishment efficiency.
• Conducted monthly internal audits supporting CLIA, CAP, and NYS compliance and CAPA programs.
• Authored validation protocols and SOPs that strengthened accuracy, quality, and test performance.
• Trained and supervised 30 laboratory employees, improving productivity and workflow consistency.

• Supervised daily testing operations and provided scheduling, mentorship, and performance oversight for 12 laboratory personnel.
• Managed CAP proficiency testing programs ensuring accurate enrollment, testing, data review, and result submission.
• Applied Lean Six Sigma practices to improve workflow and turnaround times while maintaining strict CLIA/CAP compliance.
• Optimized workflows and laboratory procedures, significantly reducing turnaround times.
• Strengthened regulatory compliance by updating policies, maintaining documentation, and ensuring audit readiness.
• Resolved process discrepancies in partnership with QA, improving data accuracy and testing reliability.
• Enhanced staff performance through targeted training, competency assessments, and ongoing development.
• Managed departmental budget efficiently by identifying cost-saving opportunities and optimizing resource use.

• Executed high-complexity generalist testing in chemistry, hematology, urinalysis, and microbiology within fast-paced acute care hospital.
  Conducted specimen analysis, verified results, and maintained quality control measures in compliance with CLIA, CAP, and hospital regulatory standards during all laboratory operations.

• Directed daily operations of high-volume reference laboratory, supervising sample processing, quality control, staffing, and regulatory compliance while ensuring timely, accurate testing and adherence to FDA, CLIA and CAP standards.

• Conducted high-complexity generalist testing across Hematology, Chemistry, and UA, maintaining rigorous result verification, quality control procedures, and instrument upkeep within hospital laboratory compliant with CLIA, CAP, and JCAHO standards.

Performed high-complexity clinical testing in Toxicology and Hematology/Coagulation/UA, quality control, and instrument maintenance in a high-volume reference laboratory under CLIA and CAP standards.

Supported clinical testing operations through specimen processing, assay setup, quality control monitoring, and instrument support in a regulated laboratory environment.