Growth-focused, multifaceted, and highly analytical professional with broad-based experience in biotechnology, pharmaceutical, healthcare, and cosmetic field. Equipped with proven ability to provide effectual support and lead various development and implementation initiatives while maintaining compliance with set standards and procedures. Adept at designing and presenting effective systems, processes, and tools; and driving continuous operational improvements. Knowledgeable of Title 21 Code of Federal Regulations Part 11, current good manufacturing practices (cGMP), Good automated manufacturing practice (GAMP 5), fundamentals of biotechnology, and systems development life cycle methodology (SDLC) methodologies Articulate communicator, with well-honed interpersonal aptitude, essential in establishing and maintaining positive working relationship with individuals of diverse backgrounds. Bilingual in English and Spanish.
Listed skills include Engineering, Validation, Project Management, Quality Assurance, and 25 others.