Klaribell Cuadrado Rivera

Results-Oriented Professional with Quality Control experience for multinational manufacturing industry. Possess hands-on expertise in analytical testing of raw material, finished product, stability, and validations. Broad working knowledge and full trained in GMPs, SOPs, GLPs, FDA, ACS regulations, European, Japanese and US Pharmacopoeias, laboratory techniques, statistical methods, project management, and Lean 5S methodology. Proven performer in a fast-paced regulated environment, ability to work under pressure, manages multiple priorities, and produce top quality work. Possess management and leadership skills, as well as effective communication. Full skilled in computer systems: MS Office, Microsoft Word, Power Point, Microsoft Excel. Strong exposure to software such as: LIMS, Empower, Lab X, SAP, e-Lab. Bilingual: English and Spanish. Seasoned Specialist offering 18 years of comprehensive experience interpreting and implementing quality assurance standards and investigating customer complaints and non-conformance issues. Practiced and knowledgeable professional possessing excellent problem solving and analytical skills paired with strong knowledge of QA terms, tools and methodologies. Committed to improving overall business processes.

• Worked under a closure environment of pharmaceutical plant, with the responsibility of achieving the primary goal of completing the analysis of promised lots to the marked with the established quality.
• Participate in the reorganization of the laboratory using the Lean 5S methodology, optimizing laboratory operations, which was presented in the Quest Professional competition of the Puerto Rico Industrial Association and obtained a silver award.
• Carry out supervision work as support in the laboratory.
• Participated during the product validation of a new product that was launched to the marked ahead of the established date.
• Creation of Analytical Data Sheet to support documentation (right the first time).
• Performed laboratory testing and analysis accurately, reliably, and safely, and in compliance with regulatory and company regulations ensuring that reported data is attributable, legible, original, contemporaneous, accurate, and errorfree.
• Actively participate in Method Validation/ Method Transfer of New Product Introduction to reduce the cycle time of the analysis.
• Participated in laboratory audits to maintain the laboratory in optimal conditions and in compliance with established current GMP guidelines and regulations.
• Creation of SOP for different analyzes and instruments.