Quality Control Analyst

Description

Job Summary: Quality Control Analyst responsible for ensuring that products, samples, and raw materials meet specifications, regulatory standards, and quality requirements through testing and analysis. Key Highlights: 1. World leader in human vaccines for over 100 years 2. Opportunity for diversified professional growth and development 3. Innovation in vaccine manufacturing and disease prevention **Position**: *Quality Control Analyst* * *Location: Cuautitlán* * *100% on-site* * *Contract type: Temporary, 1 year* **About the Position** *We are a global leader in human vaccines for over 100 years. We develop and manufacture a broad portfolio of high-quality vaccines to protect people worldwide from serious diseases at every stage of life. We continue to experience strong growth and deliver best-in-class products to protect against many diseases, including influenza, meningitis, polio, whooping cough, bronchiolitis, and more. We improve people’s lives by developing innovative vaccination solutions against numerous diseases.* *We innovate in vaccine manufacturing through digitalization and engage in partnerships for disease prevention, to sustainably maximize the impact of vaccination.* *We provide employees with opportunities to grow and encourage them to build diversified professional careers within Sanofi.* **Our Team:** The Quality Control department is responsible for performing tests, analyses, and evaluations on bulk product, intermediate product, finished product, samples from critical systems, raw materials, and primary and secondary packaging materials, ensuring compliance with established specifications, applicable regulatory standards, and quality requirements. It ensures the reliability of analytical results through proper use of instrumental techniques and validated laboratory methods, as well as correct interpretation and recording of data. **Key Responsibilities:** * Execute analytical testing promptly, ensuring adherence to committed scheduled plans. * Perform tasks in accordance with cGMP and HSE requirements, as well as related instructions, procedures, and records. * Record all expected raw data, calculations, and task-related information to comply with cGMP and data integrity requirements. * Ensure that you are trained and qualified for assigned analytical tests requiring qualification. * Timely review quality control data from tests performed by other analysts, ensuring adherence to committed scheduled plans. * Promptly report any quality or HSE events (e.g., deviations, OOX) to your supervisor to ensure appropriate investigation and impact assessment. * Actively participate in any investigation when involved, to ensure investigations and impact assessments are conducted appropriately. * Execute assigned CAPAs related to remediation plans and continuous improvement initiatives. * Ensure your laboratory/facilities and laboratory instruments are maintained in a state of quality and safety to guarantee their proper use. **About You** * **Experience**: Analytical experience in physicochemical and/or microbiological testing within the pharmaceutical industry. Experience in vaccines and biologics is desirable. * **Soft Skills**: Decision-making, problem analysis, communication, analytical mindset, and orientation toward continuous improvement. * **Technical Skills**: Development of analytical method validation protocols, knowledge and execution of analytical transfers, knowledge of chromatography, protein content determination, seal integrity testing—desirable. * **Education**: Bachelor’s degree in chemistry-pharmaceutical fields. * **Languages**: Basic-to-intermediate English **Pursue Progress, Discover Extraordinary** Better is out there. Better medicines, better outcomes, better science. But progress doesn’t happen without people: people from different backgrounds, in different locations, performing different functions—all united by one thing: the desire to make miracles real. So let’s be those people. At Sanofi, we offer equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and learn about our Diversity, Equity & Inclusion actions at sanofi.com. \#LI\-LAT \#LI\-Onsite null