• Over 20 years of combined experience in manufacturing operations and in quality management.8 years of managerial experience in the different facets of an emerging biomedical company and 10 years of progressive experience with Abbott Laboratories, a global leader in the pharmaceutical and medical manufacturing industries.• Project management experience in the areas of quality assurance, quality control, validation, statistical support, purchasing, incoming quality control, risk management, labeling, regulatory affairs, production planning, and scheduling to name a few • Comprehensive understanding of international manufacturing/testing procedures of in-vitro diagnostics in a GMP, ISO 9001, safety and regulatory compliant environment • Master’s degree from Germany in Biotechnology Engineering • Six Sigma Lean Green Belt Trained • Certified Process Picture Map Developer & Approver - Talsico International • Very committed and reliable, work hard to achieve results. Team player, leader and coachable. Very good work ethics from the experience in the German industry yet well-rounded understanding of the American industry. Internationally minded, multilingual and culturally sensitive.
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Director Of QualityStembiosys, Inc. Feb 2022 - PresentSan Antonio, Texas, Us- Oversees the quality and consistency of the company's day-to-day operations and of the technology transfer from research and development to manufacturing- Technical understanding of manufacturing processes and operations- Extensive familiarity with quality assurance procedures- Develops, implements, and enforces best practices and methodologies for manufacturing and testing processes, related documentation, material control, equipment validation, personnel training, and complaint handling- Manages the company’s quality control efforts, including the review of manufacturing and testing records and the release of batches for sale, ensuring that all products meet quality standards- Drives identification and resolution of quality issues contributing to continuous improvement- Creates and maintains the cost of goods of all the company's products -
Quality ManagerStembiosys, Inc. Oct 2017 - Jan 2022San Antonio, Texas, UsManaged the company’s quality control efforts, including the review of manufacturing and testing records and the release of batches for sale, ensuring that all products meet quality standards. -
Production ManagerStembiosys, Inc. Apr 2015 - Sep 2017San Antonio, Texas, UsProduction manager:(Stembiosys, Inc is an emerging biotechnology company focused on the progress of regenerative medicine) • Coordinates and oversees the planning, scheduling, material control of the manufacturing, labeling/packaging of all in-house products in a timely and cost-effective manner • Implemented and maintains manufacturing SOPs, Batch Records, forms• Implemented and monitors quality standards, reinforcing quality control and tracking to meet quality objectives• Identifies and Resolves deviations while working on continuous improvement efforts within manufacturing operations• Assist R&D projects and experimental design while coordinating activities in the transfer of technology from Process Development to Manufacturing• Manages manufacturing performance as well as material and equipment resources• Manages personnel performance & development• As safety warden, ensures safety practices and procedures in compliance with OSHA -
Member Of "Project Transition Usa" Group On Linkedin ♦ Supporting Transitioning Military & VetsProject Transition Usa Jan 2023 - PresentGreater Tampa Bay, Florida, UsAs a Veteran's spouse, I understand making that transition can be difficult. As part of this group, I provide training and assist transitioning military personnel on their journey to find civilian jobs. My goal is to help a fellow Veteran make the right connection which to me can make all the difference in the world.Project Transition USA is an organization dedicated to helping transitioning military veterans & their families find meaningful and rewarding civilian careers. All members of our LinkedIN group work together to utilize the powerful networking & job search technology of LinkedIN in support of this goal.In addition to managing this group, Project Transition USA was the first to conduct a LinkedIN Job Search Workshop on a U.S. military base (MacDill Air Force Base, Home of U.S. Central Command -- Nov. 16, 2012). They have been conducting free monthly workshops on MacDill ever since, and plan to expand these trainings to every military base in the country.We invite you to show your support by participating in our group and hiring U.S. veterans at every opportunity!Join our group here: https://www.linkedin.com/groups/Project-Transition-USA-4842096/aboutTo learn more about Project Transition USA, visit: www.ProjectTransitionUSA.org -
Head Change Control SpecialistAbbott Jun 2011 - Aug 2014Abbott Park, Illinois, Us- Successfully executed activities associated with product service level and quality/compliance/regulatory with remarkable timeliness and precise project status reports- Independently led and coordinated interdepartmental projects while managing cross-functional teams and executing Design Plans & Change Requests for the entire product life cycle with an understanding of profitability, priorities and responsibilities. Highly proficient in Change Control projects of wide ranging categories and complexities, local and global including yet not restricted to: • Product and component manufacturing/testing • Process and method optimizations • Cost improvement• Analytical testing• Product reformulation • Assay standardization • Product requirements • Purchased material and in process material • Facilities, utilities and equipments • ER/CAPA • Product site transfer• Support of product launch -
Head Product SpecialistAbbott Mar 2006 - May 2011Abbott Park, Illinois, Us- Conducted and evaluated Troubleshooting, Investigation and Complaint testing on non-conforming or low performing products in order to support product improvement as well as product launch/transfer while meeting internal timeliness goals- Successfully planned and completed:• Site transfers, implementation and validation of new manufacturing/testing processes (e.g. test methods conversion and new assay standardization) within established project timelines • The optimization of testing and manufacturing processes resulting in reduced cycle times, manufacturing frequency and material destruction• The Green Belt Project for Calibrator Fill volume Reduction leading to up to $800 K savings the following year -
Product Specialist IAbbott Apr 2003 - Feb 2006Abbott Park, Illinois, UsReliably and timely executed the manufacturing and testing processes of in vitro diagnostica product component (microparticle, conjugate, controls, calibrators etc) following Safety/GMP/ISO 9001 guidelines and company’s Quality Assurance procedures thus achieving appropriate product quantity and quality at target manufacturing cycle time and planned delivery dates while preventing careless human and manufacturing errors (ER).
Claudia Bailey Education Details
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Technische Universität BerlinBiotechnology Engineering -
San Diego State University"Use Of Pluripotent Mesenchymal Cells Of Transgenic Gfp-Mice As A Model For Gene Therapy" -
Murdoch University"Optimization Of The Culture And The Carotenoid Production Of The Green Algae Chlorella Fusca"
Frequently Asked Questions about Claudia Bailey
What company does Claudia Bailey work for?
Claudia Bailey works for Stembiosys, Inc.
What is Claudia Bailey's role at the current company?
Claudia Bailey's current role is Director of Quality at Stembiosys.
What schools did Claudia Bailey attend?
Claudia Bailey attended Technische Universität Berlin, San Diego State University, Murdoch University.
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