Ms. Cantara has more than 15 years of experience in Analytical Quality Control and Assurance. As a Consultant at LBG, she supports clients in the development and management of quality systems to support cGxP, ISO:17025, and medical device programs. A Quality Assurance SME, she is adept at selecting a phase-based approach for clients and growing programs by creating a full suite of Quality documents, managing lot disposition, IND authoring and submission review, and auditing and selection of vendors as well as label management throughout the clinical lifecycle.
In leadership roles at contract testing and contract development and manufacturing organizations, she has contributed to the quality management of products in research and development, clinical development, and commercialization. She also has expertise in a wide range of analytical laboratory testing techniques, including all compendial-based testing, HPLC/UPLC, FTIR, and UV-Vis.
As an analytical chemist, Ms. Cantara authored and reviewed SOPs, protocols, and batch records and focused on root cause analysis for documenting deviations and CAPA. In a previous role at LSNE, Inc., she executed numerous successful method transfer and validations on time and on budget, including validations for critical in-process testing. She operated and improved the finished drug product visual inspection training program to qualify operators by enhancing classroom training, building and maintaining the testing kit, and developing a library of defects.
She has represented the analytical laboratory as a subject matter expert during audits for both prospective and current clients as well as the FDA, MHRA regulatory bodies, and A2LA accreditation. She provides a hands-on laboratory approach that combines both the analytical and quality mindset to assure clients of their compliance to regulation, safety of the manufacturing process, and rapid progression of their development programs.
Ms. Cantara received her B.S. in Biology from Northeastern University.
