Alma Lastrella
San Diego,CA
Summary
Accomplished senior management professional with extensive experience in high complexity testing, laboratory operations, quality systems, and regulatory compliance across healthcare, clinical diagnostics, and biotech industries. Strategic leadership and operational excellence drive organizational success. Skilled at navigating complex challenges, fostering a culture of accountability, and adapting to evolving business needs. Strong decision-making, effective communication, and building high-performing teams. Demonstrates excellent leadership and technical skills to ensure the integrity of laboratory functions. Proven track record in handling multiple projects effectively and delivering quality results. Specializes in operational strategic planning, quality management systems, recruitment, training, performance management, team building, and various regulatory compliance standards.
Overview
34
34
years of professional experience
1
1
Certification
Work History
Sr. Manager, CLIA Lab/ QA Manager
BIONANO LABORATORIES
04.2021 - Current
- Responsible for day-to-day operations of CLIA and CAP accredited laboratory from sample management, testing, data analysis and reporting of results. Performed sample DNA extraction, labeling, DNA quantitation, and chip loading onto Saphyr instrument. Monitor equipment maintenance and calibration, reagents and supply inventory management inventory. Responsible for recruitment, training, competency assessments, performance management of laboratory personnel. Prepare department annual operating plan and budget, cost saving initiatives and strategic planning. Manage onboarding new clients and contracts, creating new ordering provider accounts, laboratory service agreements and clinical customer support. Oversee quality and regulatory compliance, monitor quality improvement initiatives, quality metrics and key performance indicators (KPI) in the laboratory. Led safety and quality meetings, investigated, documented and resolved nonconforming events, deviations, customer complaints and monitored effectiveness of corrective and preventative action plans (CAPA).
- Key Accomplishments:
- Developed and implemented policies, procedures for document control and quality management systems.
- Collaborated with project teams in the validation and implementation of Optical Genome Mapping laboratory developed tests for FSHD, HEME and Constitutional Postnatal and Prenatal whole genome structural variants.
- Executed equipment IQ, OQ, PQ protocols and reagent qualifications.
- Organized and prepared the laboratory for initial CDPH/CLIA and CAP on-site inspections and successfully passed with zero deficiencies.
- Validated and implemented MediaLab electronic document management systems.
- Coordinated the relocation and consolidation of our second site lab (Lineagen acquired by Bionano) genetic testing services from Salt Lake City to San Diego.
- Provided strong leadership to enhance team productivity and morale.
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
General Laboratory Supervisor II
UCSD HEALTH
10.2020 - 06.2022
- Performed high throughput rapid COVID-19 diagnostic testing using Perkin Elmer and ThermoFisher platforms. Oversee 30 testing and non-testing personnel, prepare monthly staff schedule, hiring, training, competency assessments and performance evaluation of lab personnel. Performed validation of laboratory developed test (LDT), equipment validation, reagent qualification, and monthly reviews of equipment maintenance and QC records.
- Key Accomplishments:
- Authored quality, equipment and technical policies and procedures, test validation plans, equipment qualification.
- Prepared quality metrics, safety audits/findings response for monthly/quarterly quality meeting review.
- Led safety and internal audits, vendor audits and CLIA/CAP inspections.
- Collaborated with R&D group on COVID-19 laboratory testing projects for journal publication.
- Reduced turnaround time for test results by optimizing workflows and laboratory procedures.
CLIA/CAP/Quality Consultant
AMPRION INC.
08.2018 - 10.2020
- Organized and set-up equipment and supplies for a new laboratory and submit the application for CLIA certification. Prepared and implemented laboratory policies and procedures for Quality Management Systems, document control and validation protocols for laboratory developed test (LDT). Installed and validated lab instruments/equipment, reagents, materials and supplies for (LDT) validation. Established the Quality system program, prepared Lab SOPs and CLIA applications.
- Key Accomplishments:
- Implemented document and quality management systems, safety, and operational infrastructure for clinical laboratory processes.
- Initiated Quality, Safety, document control, laboratory policies and procedures following the Quality System Essentials, CLSI standards, CLIA and CAP checklist.
- Created and implemented procedures for materials and supplies qualification, equipment validation, calibration, and preventive maintenance.
- Collaborated with R&D in writing design control and test method development for verification and validation of Laboratory Developed Test.
Laboratory Manager
EPIC SCIENCES
06.2015 - 10.2018
- Responsible for the daily laboratory operations, NGS and Cytogenetic testing, equipment, reagent/ supply inventory management and quality control. Oversee CLIA and CAP testing for liquid biopsy for single cell cancer biomarker analysis using the CTC (Circulating Tumor Cells) technology for rare cell detection and characterization platform. Provide leadership for 12 direct reports (CLS, Lab Associates and Lab Assistants). Monitored cell line production, reagent/supply inventory and quality control materials for reagents and antibody qualifications. Reviewed orders and shipment of supply and reagent kits to internal and external customers. Performed CAPA and NCMR for out of specifications and protocol deviations. Left company due to reduction in force/reorganization.
- Key Accomplishments:
- Streamlined the process for ordering raw materials and supplies inventory, reagent qualification, optimization of cell culture and antibodies for clinical testing.
- Created and implemented new protocols, procedures, and batch records to help improve laboratory efficiency.
- Organized and prepared the laboratory for CLIA certification and CAP accreditation and successfully passed both inspections with no deficiencies.
- Collaborated with cross-functional teams in writing the validation plan for the new LIMS system.
- Fostered a positive working environment by promoting open communication among team members and addressing any conflicts promptly.
Sr. Manager, Laboratory Operations
SEQUENOM LABORATORIES
12.2011 - 06.2015
- Managed the day to day pre-analytical, analytical, and post-analytical operations of the molecular diagnostic testing laboratory. Oversee the test performance, analysis and reporting of non-invasive prenatal tests (NIPT) that detect fetal chromosomal genetic abnormalities for trisomy 13, 18 and 21. Responsible for strategic planning, department budget, and implementation of new versions of laboratory developed tests, quality systems and other analytical methods. Managed the recruitment, hiring, training, employee development and performance management of 25 testing and non-testing personnel.
- Key Accomplishments:
- Implemented new and revised policies, procedures, and safety practices for molecular testing process.
- Collaborated with Technical group in the validation and implementation of Materni T21 Plus and VisibiliT Laboratory Developed Test (LDT) using Illumina HiSeq 2000/2500 Next Generation Sequencing System platform and Hamilton automated sample processing system.
- Executed 5S Lean/ Six Sigma process in Accessioning/Sample Management, DNA Isolation, Library Preparation and Sequencing areas.
- Improved staff efficiency and productivity by 90% by re-aligning staff resources and cross-training staff to cover other testing departments.
- Led cross-functional teams in implementing new process validation, assay optimization, assay transfer and LIS/LIMS interface projects.
- Created and implemented troubleshooting guides to standardize corrective actions for equipment and testing issues.
- Successfully passed CAP, CLIA, New York accreditations and other internal and external quality audits.
- Improved proficiency testing process and developed training and competency assessment program for laboratory personnel.
Sr. Clinical Laboratory Scientist- Lead
MILLENNIUM LABORATORIES
06.2010 - 12.2011
- Responsible for the technical functions, data review and reporting of laboratory test results. Provided oversight of process improvement activities including quality, safety, document management, QC, and proficiency testing. Performed troubleshooting and resolution of instruments and testing performance issues. Facilitated and performed internal audits and gap analysis of the laboratory testing process, training and competency and procedural revision in preparation for CLIA, CAP and New York State inspection. Performed testing and data review using LC-MS/MS technology to determine drug specific identification and quantification of drugs and metabolites.
Clinical Laboratory Supervisor
SEQUENOM LABORATORIES
03.2011 - 12.2011
- Performed high complexity molecular testing procedures including DNA isolation, library preparation and sequencing, data analysis and quality control. Steered the workflow, production, data review and timely reporting of patient test results in the laboratory. Monitored and tracked sample shipment, accessioning and processing methods for timely execution of all associated testing. Responsible for staff training, competency assessments and performance reviews of direct reports.
- Key Accomplishments:
- Streamlined laboratory processes, organized workflow, and implemented a two shifts schedule for testing personnel that resulted in 95% improvement in operational efficiencies.
- Created productivity and quality metrics to track and trend key test performance for monthly QMS reports.
- Implemented validation test plans for software and Materni T21 assay version upgrades.
- Initiated cost-saving methods for lab supplies, reagents kits and materials inventory.
- Promoted to Sr. Manager, Lab Operations within 1 year of hire.
Sr. Laboratory Manager
PROMETHEUS LABORATORIES
02.2007 - 06.2010
- Managed daily operations in sample processing, quality control, equipment, reagents, and testing performance of all assays associated with Molecular Genetics, Chemistry, Oncology, and Immunology. Responsible for overall compliance with ISO, CLIA, CAP and FDA regulatory requirements, department budget, equipment management system, CAPA, deviations, occurrence management and quality systems. Established quality control and equipment maintenance and calibrations processes to monitor any deviations and non-conformances on test results. Responsible for operations, finances, and human resource management for the department. Coordinate some operational initiatives for process improvement with lab leadership and other service lines.
- Key Accomplishments:
- Led multiple projects designed for equipment and process validations for new test systems programs and software upgrades.
- Developed procedures for proficiency testing, competency assessment, and comprehensive employee training programs.
- Conducted the sample integrity project for clinical and research and development samples in preparation for IBS/IBD testing.
- Generated the monthly testing data reports and key performance indicators for Quality metrics.
- Initiated cost saving proposals and budget for lab supply inventory using Kanban system.
- Implemented monthly internal audits for CLIA, CAP, NYS compliance and other regulatory agency requirements through proper documentation and corrective actions.
- Prepared and executed validation protocols for new and existing equipment, software upgrades, new procedures, and test methods.
- Developed training manuals and checklist to improve test efficiency, quality, and employee’s productivity.
- Facilitated employee training, competency assessments, and performance reviews for 30 lab employees.
- Improved laboratory efficiency by streamlining workflows and implementing process improvements.
Laboratory Supervisor
QUEST DIAGNOSTICS
01.2005 - 02.2007
- Responsible for scheduling and mentorship of 15 laboratory personnel and managing the daily testing operations. Administered internal and external proficiency programs that included enrollment, testing, data review, evaluation and reporting of CAP and New York proficiency test results. Performed all testing processes in Hematology, Chemistry and Toxicology department, reviewed and reported test results and served as a technical resource for analytical problems, investigation and troubleshooting of testing and equipment issues. Maintained staffing by interviewing, hiring, training, performed personnel competency assessments and work performance reviews. Completed training and implementation of Lean Six Sigma process in the laboratory. Left company due to lab closure and relocation to Los Angeles.
Clinical Lab Scientist III-Generalist
Sharp Chula Vista Medical Center
01.2004 - 01.2006
Laboratory Operations Manager
American Red Cross, National Testing Laboratory
01.2000 - 01.2005
Clinical Laboratory Scientist II – Generalist
Alvarado Hospital Medical Center
01.1998 - 01.2003
Clinical Laboratory Supervisor
American Red Cross, National Testing Laboratory
01.1998 - 01.2000
Clinical Laboratory Scientist II
Quest Diagnostics Inc.
01.1993 - 01.1998
Clinical Laboratory Scientist I
Miles Laboratories (Acquired by Bayer Corp)
01.1992 - 01.1993
Education
Bachelor of Science - Medical Technology
University of the Immaculate Conception
MBA -
University of Phoenix
San Diego, CA02.2025
Skills
- Strategic operational planning
- Quality assurance systems
- Operational efficiency management
- Strategic planning expertise
- Cross-departmental collaboration
- Recruitment expertise
- Employee training and performance evaluation
- Team collaboration
- Laboratory test validation
- Regulatory compliance oversight
- Expertise in regulatory compliance accreditations (CDPH, CLIA, CAP, New York State, JCAHO)
- FDA and ISO 15189 audit experience
- Experienced CAP inspector
Affiliations
- Clinical Laboratory Management Association (CLMA)
- American Association of Blood Banking (AABB)
- Association for Diagnostics & Laboratory Medicine (ADLM)
- American Society of Clinical Pathology (ASCP)
Certification
- California Clinical Laboratory Scientist. Generalist, MTA 35456
- State of Nevada Clinical Laboratory Technologist, 26595TGS-0
Publications
- Comparison of heat-inactivated and infectious SARS-CoV-2 across indoor surface materials shows comparable RT-qPCR viral signal intensity and persistence., Salido RA, Cantú VJ, Clark AE, Leibel SL, Foroughishafiei A, Saha A, Hakim A, Nouri A, Lastrella AL, Castro-Martínez A, Plascencia A, Kapadia B, Xia B, Ruiz C, Marotz CA, Maunder D, Lawrence ES, Smoot EW, Eisner E, Crescini ES, Kohn L, Vargas LF, Chacón M, Betty M, Machnicki M, Wu MY, Baer NA, Belda-Ferre P, Hoff P, Seaver P, Ostrander RT, Tsai R, Sathe S, Aigner S, Morgan SC, Ngo TT, Barber T, Cheung W, Carlin AF, Yeo GW, Laurent LC, Fielding-Miller R, Knight R., bioRxiv, 2021-07-19, 10.1101/2021.07.16.452756, 34312621, PMC8312891
- Analysis of SARS-CoV-2 RNA Persistence across Indoor Surface Materials Reveals Best Practices for Environmental Monitoring., Salido RA, Cantu VJ, Clark AE, Leibel SL, Foroughishafiei A, Saha A, Hakim A, Nouri A, Lastrella AL, Castro-Mart´ınez A, Plascencia A, Kapadia BK, Xia B, Ruiz CA, Marotz CA, Maunder D, Lawrence ES, Smoot EW, Eisner E, Crescini ES, Kohn L, Vargas LF, Chac´on M, Betty M, Machnicki M, Wu MY, Baer NA, Belda-Ferre P, Ho PD, Seaver P, Ostrander RT, Tsai R, Sathe S, Aigner S, Morgan SC, Ngo TT, Barber T, Cheung W, Carlin AF, Yeo GW, Laurent LC, Fielding-Miller R, Knight R., mSystems, 2021-12-21, 10.1128/mSystems.01136-21, 34726486, PMC8562474
Timeline
Sr. Manager, CLIA Lab/ QA Manager
BIONANO LABORATORIES
04.2021 - Current
General Laboratory Supervisor II
UCSD HEALTH
10.2020 - 06.2022
CLIA/CAP/Quality Consultant
AMPRION INC.
08.2018 - 10.2020
Laboratory Manager
EPIC SCIENCES
06.2015 - 10.2018
Sr. Manager, Laboratory Operations
SEQUENOM LABORATORIES
12.2011 - 06.2015
Clinical Laboratory Supervisor
SEQUENOM LABORATORIES
03.2011 - 12.2011
Sr. Clinical Laboratory Scientist- Lead
MILLENNIUM LABORATORIES
06.2010 - 12.2011
Sr. Laboratory Manager
PROMETHEUS LABORATORIES
02.2007 - 06.2010
Laboratory Supervisor
QUEST DIAGNOSTICS
01.2005 - 02.2007
Clinical Lab Scientist III-Generalist
Sharp Chula Vista Medical Center
01.2004 - 01.2006
Laboratory Operations Manager
American Red Cross, National Testing Laboratory
01.2000 - 01.2005
Clinical Laboratory Scientist II – Generalist
Alvarado Hospital Medical Center
01.1998 - 01.2003
Clinical Laboratory Supervisor
American Red Cross, National Testing Laboratory
01.1998 - 01.2000
Clinical Laboratory Scientist II
Quest Diagnostics Inc.
01.1993 - 01.1998
Clinical Laboratory Scientist I
Miles Laboratories (Acquired by Bayer Corp)
01.1992 - 01.1993
Bachelor of Science - Medical Technology
University of the Immaculate Conception
MBA -
University of Phoenix
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