When you are part of the team at Thermo Fisher Scientific, you will do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you will be supported in achieving your career goals.Location/Division Specific InformationPharmaceutical Services Group – Oral Solid DosageHow will you make an impact?The investigation Specialist is part of a team responsible to evaluate, analyze, and manage all deviations for all of manufacturing / packaging phases. Uses expert knowledge of cGMP regulations and project management to ensure manufacturing / packaging readiness.What will you do?Lead manufacturing / packaging investigations Support daily huddle meetings related to investigationsPractices and promotes safe work habits and adheres to safety procedures and guidelinesUtilizes manufacturing / packaging process knowledge and investigation skills to identify and resolve manufacturing / packaging issues and drive continuous improvement in process operationsSupports cross-functional investigations from the manufacturing /packaging standpoint with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and TechnologySupports cross-functional company goals for Site MetricsBuilds cross-functional relationships and enhances relationships with team membersWorks cooperatively with others to meet group and organizational goalsParticipates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies, and regulations.Participate in client and planning meetings as requestedHow will you get here? EducationBachelor's degree in Science or related field is required, Chemist or Chemical Engineer, preferable.Experience Four (4) to Six (6) years' of progressive experience in a regulated industry writing technical investigations for manufacturing / packaging area, within oral solid dosage.Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.Knowledge, Skills, AbilitiesStrong understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and current Good Documentation Practices (cGDP).Works on investigations of moderate to high complexity regarding compliance of processes and product within quality & regulatory compliance and data integrityStrong in mathematics and statistic skills / Analytical Skills/ Technical writing technics.Technical knowledge in oral solid dosageAbility to work in a fast paced environment, able to multi-task and results-oriented.Self-starter, mature, independent, and dependable.Effective time management and prioritization skills.Excellent interpersonal skills to establish and maintain effective working relationships with internal and external customers.Highly effective communication verbal and written in Spanish & English.Strong proficiency in Microsoft office and software skills, such as TrackWise and Minitab).At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer. To Apply, please click the following link: https://thermofisher.contacthr.com/77434255
