Rebecca Lutz Email and Phone Number
Rebecca Lutz work email
- Valid
- Valid
- Valid
- Valid
Rebecca Lutz personal email
- Valid
Rebecca Lutz phone numbers
My current mission is to ensure the highest standards of quality, safety, and efficacy in the manufacturing of biological immunotherapy products for phase I and II clinical FDA trials. With over 17 years of experience in quality assurance and microbiology, I am a passionate and dedicated Quality Assurance Scientist at Gradalis, a biotechnology company developing personalized therapeutics to treat cancer. I manage key quality functions, such as deviation resolution, batch record review and release, OOT assessment, and change control, and communicate effectively with remote supervision. I also have expertise in Investigational New Drug (IND) filing, cGMP, and GDP compliance. I have a proven track record of leading successful audits, managing deviations, and driving continuous improvement in quality systems and processes. I have reduced external assessment findings by 95%, implemented change controls spanning multiple departments, and authored the CMC section of the annual FDA report. I have also attained and maintained ISO-based accreditation for fungal analysis, expanded the microbiology team, and designed a laboratory information management system (LIMS) module for streamlined data input and report generation. I have strong skills in risk management, root cause analysis, and regulatory compliance. I am also a leader, a problem-solver, a mentor, and a project manager, who values collaboration, innovation, and excellence. I am always eager to learn new skills, face new challenges, and contribute to the advancement of science and medicine.Email: lutzjrs@gmail.comIndustry experience: • Manufacturing - Pharmaceutical, Biopesticides• Laboratory Production - Environmental • Research - Biopesticides, Bioremediation.Regulatory / Policy-generating agencies: • Pharmaceutical (FDA)• Environmental Production (EPA, OMRI)• Industrial Hygiene (ISO/EPA/OSHA/NVLAP/AIHA/Texas legislature)Specialties:• Investigational New Drug (IND) Filing• Internal/External Audits• cGxP (cGMP, cGDocP, cGLP) Compliance• Root Cause/FMEA Analysis• 21CFR Part 211, 600, 610• Quality Policy • Risk Management• Corrective Action/Preventive Action (CAPA)• Continuous Improvement• Deviation and Out of Tolerance (OOT) • SOP and Work InstructionPeople skills• Leadership• Effective Communication• Problem-Solving• Mentoring and Training• Project ManagementSoftware• Microsoft Excel (Expert)• Microsoft Word (Expert)• Microsoft PowerPoint• Microsoft Teams• Adobe Acrobat• QuickBase• Box• ZenQMS• Zoom
Gradalis, Inc.
View- Website:
- gradalisinc.com
- Employees:
- 25
-
Director Of Quality AssuranceGradalis, Inc.Texas, United States
-
Quality Assurance Scientist IiGradalis, Inc. Feb 2019 - PresentCarrollton, Texas, UsGradalis 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.
-
Quality System ManagerMoody Labs Jul 2011 - Feb 2019Farmers Branch, Tx, UsMoody 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. -
Microbiology Technical ManagerMoody Labs Apr 2001 - Feb 2019Farmers Branch, Tx, UsManaged 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.
Rebecca Lutz Skills
Rebecca Lutz Education Details
-
Montana State University-BozemanMicrobiology -
Montana Technological UniversityEnvironmental Engineering
Frequently Asked Questions about Rebecca Lutz
What company does Rebecca Lutz work for?
Rebecca Lutz works for Gradalis, Inc.
What is Rebecca Lutz's role at the current company?
Rebecca Lutz's current role is Director of Quality Assurance.
What is Rebecca Lutz's email address?
Rebecca Lutz's email address is rl****@****abs.com
What is Rebecca Lutz's direct phone number?
Rebecca Lutz's direct phone number is +197224*****
What schools did Rebecca Lutz attend?
Rebecca Lutz attended Montana State University-Bozeman, Montana Technological University.
What are some of Rebecca Lutz's interests?
Rebecca Lutz has interest in Animal Welfare, Arts And Culture, Health.
What skills is Rebecca Lutz known for?
Rebecca Lutz has skills like Laboratory, Quality Assurance, Sop, Indoor Air Quality, Aseptic Technique, Quality System, Quality Control, Glp, Environmental Awareness, Environmental Compliance, Microsoft Excel, Quality Management.
Who are Rebecca Lutz's colleagues?
Rebecca Lutz's colleagues are Eli Gutierrez, Laura Stanbery Nejedlik, Ph.d., Rachel Prange, Fabienne Kerneis-Stewart, Derek Nemunaitis, Brenda Marr.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial