Analyst - QC

Description

Summary: The Senior Analyst - Quality Control will ensure the quality and compliance of Eli Lilly's pharmaceutical products through analytical testing and data review within Brazilian operations. Highlights: 1. Perform complex chemical and physical testing on finished products. 2. Investigate out-of-specification (OOS) and out-of-trend (OOT) results. 3. Train and mentor junior QC analysts on analytical techniques. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life\-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Senior Analyst \- Quality Control Eli Lilly do Brasil Ltda Job Summary The Senior Analyst \- Quality Control will play a critical role in ensuring the quality and compliance of Eli Lilly's pharmaceutical products through the meticulous execution of analytical testing and data review within our Brazilian operations. Job Responsibilities * Perform complex chemical and physical testing on finished products in accordance with cGMP, pharmacopoeial monographs, and internal specifications. * Utilize and maintain a variety of laboratory equipment, including but not limited to HPLC, UPLC, UV\-Vis spectrophotometers, dissolution apparatus, and titrators. * Conduct method activities for analytical procedures as required. * Review and approve analytical data generated by junior analysts, ensuring accuracy, completeness, and compliance with established procedures and regulatory requirements. * Investigate out\-of\-specification (OOS) and out\-of\-trend (OOT) results, identify root causes, and implement corrective and preventive actions (CAPA). * Participate in the calibration, qualification, and maintenance of laboratory instrumentation. * Develop and revise standard operating procedures (SOPs), test methods, and other quality documentation. * Train and mentor junior QC analysts on analytical techniques, instrumentation, and regulatory requirements. * Contribute to continuous improvement initiatives within the QC laboratory, identifying opportunities for process optimization and efficiency gains. * Collaborate effectively with cross\-functional teams including Laboratory, Quality Assurance, and Regulatory Affairs. * Ensure adherence to all safety regulations and good laboratory practices (GLP). Job Qualifications * Bachelor's degree in Chemistry, Pharmacy or a related scientific discipline. * Minimum of 5 years of experience in a Quality Control laboratory within the pharmaceutical industry. * Proven expertise in performing a wide range of analytical techniques, particularly HPLC and GC. * Proven expertise in Empower system. * Strong understanding of cGMP regulations, pharmacopoeia requirements (e.g., USP, EP), and ICH guidelines. * Experience with LIMS (Laboratory Information Management System) and other relevant quality management software. * Demonstrated ability to investigate and resolve OOS/OOT results and implement CAPA. * Excellent analytical, problem\-solving, and critical thinking skills. * Strong attention to detail and accuracy in documentation and data analysis. * Ability to work independently and as part of a team in a fast\-paced environment. * Proficiency in Portuguese (written and spoken) is required; English proficiency is a strong plus. * Experience with method transfer is highly desirable. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace\-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. \#WeAreLilly