Rebecca Lutz
Quality Assurance Scientist II at Gradalis, Inc.- Claim this Profile
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English -
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Bio
Credentials
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Learning Minitab
LinkedInApr, 2018- Nov, 2024 -
Six Sigma Foundations
LinkedInApr, 2018- Nov, 2024
Experience
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Gradalis, Inc.
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United States
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Biotechnology Research
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1 - 100 Employee
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Quality Assurance Scientist II
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Feb 2019 - Present
Gradalis is a late-stage biotechnology company focused on developing and commercializing novel, personalized therapeutics to treat cancer. Managed critical Quality Assurance functions for autologous immunotherapy manufacturing in clinical trials targeting solid tumor cancers, encompassing deviation resolution, batch review and release, Out of Tolerance (OOT) assessment, and change control. Ensured effective communication with remote supervision. ACCOMPLISHMENTS • Led the… Show more Gradalis is a late-stage biotechnology company focused on developing and commercializing novel, personalized therapeutics to treat cancer. Managed critical Quality Assurance functions for autologous immunotherapy manufacturing in clinical trials targeting solid tumor cancers, encompassing deviation resolution, batch review and release, Out of Tolerance (OOT) assessment, and change control. Ensured effective communication with remote supervision. ACCOMPLISHMENTS • Led the Quality Assurance department during the supervisor's extended absences, resulting in a 35% reduction in long-standing deviations. Authored the CMC section of the annual FDA report and implemented 5 change controls spanning 3 departments. • Oversaw the submission of IND Module 3 (manufacturing section) to the FDA for an Ovarian cancer Phase III trial, adhering to eCTD guidance. Received only 2 minor questions from the FDA, with no trial holds. • Provided pivotal data for a $10 million oncology research grant application to CPRIT (Cancer Prevention and Research Institute of Texas). • Revamped Quality Policy Manual and Validation Master Plans. Received accolades from a former FDA reviewer, commending the Quality Policy Manual as one of the best he had encountered. • Analyzed data and designed presentations for FDA Type B and Type C formal meetings, contributing to the identification of critical Key Performance Indicators (KPIs) for the manufacturing process. • Extracted and standardized manufacturing data from historical paper records enabling FMEA analysis and the development of predictive models to assess product market viability. • Led the seamless transition of paper and hybrid records to a compliant electronic system, successfully converting more than 10 clinical trials covering 700+ lot master batch records and associated documentation. Show less Gradalis is a late-stage biotechnology company focused on developing and commercializing novel, personalized therapeutics to treat cancer. Managed critical Quality Assurance functions for autologous immunotherapy manufacturing in clinical trials targeting solid tumor cancers, encompassing deviation resolution, batch review and release, Out of Tolerance (OOT) assessment, and change control. Ensured effective communication with remote supervision. ACCOMPLISHMENTS • Led the… Show more Gradalis is a late-stage biotechnology company focused on developing and commercializing novel, personalized therapeutics to treat cancer. Managed critical Quality Assurance functions for autologous immunotherapy manufacturing in clinical trials targeting solid tumor cancers, encompassing deviation resolution, batch review and release, Out of Tolerance (OOT) assessment, and change control. Ensured effective communication with remote supervision. ACCOMPLISHMENTS • Led the Quality Assurance department during the supervisor's extended absences, resulting in a 35% reduction in long-standing deviations. Authored the CMC section of the annual FDA report and implemented 5 change controls spanning 3 departments. • Oversaw the submission of IND Module 3 (manufacturing section) to the FDA for an Ovarian cancer Phase III trial, adhering to eCTD guidance. Received only 2 minor questions from the FDA, with no trial holds. • Provided pivotal data for a $10 million oncology research grant application to CPRIT (Cancer Prevention and Research Institute of Texas). • Revamped Quality Policy Manual and Validation Master Plans. Received accolades from a former FDA reviewer, commending the Quality Policy Manual as one of the best he had encountered. • Analyzed data and designed presentations for FDA Type B and Type C formal meetings, contributing to the identification of critical Key Performance Indicators (KPIs) for the manufacturing process. • Extracted and standardized manufacturing data from historical paper records enabling FMEA analysis and the development of predictive models to assess product market viability. • Led the seamless transition of paper and hybrid records to a compliant electronic system, successfully converting more than 10 clinical trials covering 700+ lot master batch records and associated documentation. Show less
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Moody Labs
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United States
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Environmental Services
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1 - 100 Employee
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Quality System Manager
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Jul 2011 - Feb 2019
Moody Labs is an ISO 17025-accredited environmental laboratory that provides mold and asbestos analytical services. This position was created to meet the regulatory needs of Moody Labs while performing departmental duties. ACCOMPLISHMENTS: • Initiated, developed, and sustained the Quality Management System at Moody Labs for the mold and asbestos analysis departments using SWOT analysis principles. • Principal contact during 9 external site assessments. Reduced… Show more Moody Labs is an ISO 17025-accredited environmental laboratory that provides mold and asbestos analytical services. This position was created to meet the regulatory needs of Moody Labs while performing departmental duties. ACCOMPLISHMENTS: • Initiated, developed, and sustained the Quality Management System at Moody Labs for the mold and asbestos analysis departments using SWOT analysis principles. • Principal contact during 9 external site assessments. Reduced external assessment findings by 95%. • Orchestrated and executed 17 departmental and 7 company-wide quality system audits, ensuring adherence to industry standards. • Employed root cause analysis and FMEA tools to evaluate nonconforming work, resulting in precise corrective actions and preventive actions (CAPA) enhancing overall quality and compliance. • Digitized 200+ paper-based documents and records, enhancing security, streamlining operations, and minimizing environmental impact. • Provided testimony before the Texas Sunset Legislative Commission to advocate for the preservation of mold laws, safeguarding consumer interests, and upholding industry professional standards.
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Microbiology Technical Manager
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Apr 2001 - Feb 2019
Managed microbiologists and provided environmental mold sample analysis for homeowners, hospitals, schools, and industrial clients. ACCOMPLISHMENTS: • Attained initial accreditation and consistently secured re-accreditation with AIHA (American Industrial Hygiene Association) for fungal analysis, marking the pioneering environmental microbiology laboratory in North Texas to achieve and uphold this recognition. • Orchestrated expansion from a team of six analysts to a robust unit… Show more Managed microbiologists and provided environmental mold sample analysis for homeowners, hospitals, schools, and industrial clients. ACCOMPLISHMENTS: • Attained initial accreditation and consistently secured re-accreditation with AIHA (American Industrial Hygiene Association) for fungal analysis, marking the pioneering environmental microbiology laboratory in North Texas to achieve and uphold this recognition. • Orchestrated expansion from a team of six analysts to a robust unit of fourteen scientists, leading to a remarkable achievement of the mold division grossing $1.7 million within just one year of its inception. • Innovated a computer module for streamlined data input and report generation, resulting in a 50% boost in productivity and a significant reduction in errors within client reports. • Spearheaded proficiency sample exchanges across 9 laboratories, fostering collaboration and benchmarking. Applied non-parametric statistical data analysis with precision to monitor and ensure the accuracy of results, promoting data-driven decisions and continuous improvement. • Delivered expert legal disposition for mold lawsuits by verifying analytical results, contributing to informed and fair resolutions.
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Education
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1986 - 1990
Montana State University-Bozeman
B.S., Microbiology -
1994 - 1995
Montana Technological University
Environmental Engineering
Community
