Julieth Saportas Valencia

With a robust background at Bristol Myers Squibb, I excel in regulatory compliance and cross-functional collaboration. My expertise in process improvement and bilingual communication has significantly enhanced manufacturing efficiency, including a 50% reduction in delivery times. My leadership in auditing and technical writing underscores my ability to drive project success and compliance excellence.

Available upon request

• How to Write Procedure and Work Instruction to Reduce Human Error, Business Excellence Consulting, Inc., San Juan, Puerto Rico
• Batch Record Review Process: 2020 FDA, EU and Canada Regulatory Requirement, Key Elements of the Review Process & Emerging Technologies, Pharma Webinars
• Quality Auditor Certification (CQA), Business Excellence Consulting, Inc., San Juan, Puerto Rico
• Technical Writing Principles Applied to Regulatory Documents
• Biotechnology, Universidad de Puerto Rico, Arecibo, Puerto Rico
• Electrician and Electronic Basic Principles, Bayamon, Puerto Rico
• Computer Science: Windows, Office, Excel, PowerPoint, Word
• Statistical Software to assure repeatability and reproducibility information, Universidad Del Valle, Cali, Colombia
• Management Skills, Centro Experimental de Aprendizaje, Sena, Cali, Colombia
• Professional Ethics and Human Values, Centro Experimental de Aprendizaje, Sena, Cali, Colombia
• Sugar Chemistry and Biotechnology, Universidad Del Valle, Cali, Colombia

Over 18 years of experience in aseptic processing with isolation technology, parenteral manufacturing process, and biopharmaceutical formulation. Expertise in audit and review Batch Records, Forms, protocols, final reports, and regulatory submissions, ensuring full compliance with FDA regulations, cGMP standards, and Industry current practices., Expertise in preparing and reviewing SOPs, batch records, Forms and all document regulatory submissions to ensure compliance with FDA, cGMP, and OSHA regulations. In-depth knowledge of regulatory standards and guidelines required for the manufacturing lifecycle of parenteral and biological products., Proven ability to lead cross-functional teams, including external and internal collaboration, and manage multiple complex projects, ensuring that timelines and production goals are met while maintaining high standards of quality and compliance. Skilled in project management, time management, and prioritization in fast-paced environments, with a focus on meeting deadlines and managing competing priorities., Advanced technical writing skills, including the development of Procedures, Batch Record and Forms, technical reports, and regulatory documents. Strong communication skills (both written and oral) in English and Spanish, with the ability to translate complex technical concepts to diverse audiences., Strong troubleshooting and root cause analysis skills, with a focus on process optimization to resolve issues, reduce variability, and improve efficiency. Knowledge in product and process development, including manufacturing scale-up, continuous process improvement, and troubleshooting, while ensuring all activities conform to departmental standards and comply with regulatory requirement. Proficient in Statistical Process Control (SPC) and Process Capability analysis to enhance manufacturing performance and ensure product consistency.