Associate Quality Technician – Sanofi Pasteur – Swiftwater, PA, USA
Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. We distribute more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Our company has more than 13,000 employees worldwide working in 14 production and/or R&D sites with more than 50% of staff devoted to industrial operations (IO). Industrial Operations (IO) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi Pasteur provides associates in IO a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.
The core hours and working schedule for this position are Monday through Friday, 10:00am to 6:30pm .
This position will perform Quality inspections on incoming raw materials, which may include documentation verification, statistical sample removal, and identification tagging of materials by strictly adhering to sanofi pasteur policies and procedures and cGMP. They will also be required to perform cleaning of work areas, equipment, and any other jobs as required, ensure all duties are completed on time, and complete required Safety and Compliance training and associated training modules as assigned.
∙ Performs inspection, sampling, testing, and release of raw materials by strictly adhering to SOPs, SWIs, material specifications, Federal Regulations, cGMP, training modules, sanofi pasteur policies and procedures, and safety guidelines. These activities are performed as dictated by PQ MR management to meet the demands of the production schedule.
∙ Maintains laboratory in a safe and compliant state. Manages inventory of raw material sampling utensils, sample containers, and safety supplies. Performs cleaning of laboratories sampling equipment as needed.
∙ Process and inspect product samples from contract manufacturers. Ensure cold chain of custody is kept on samples and samples are distributed to the applicable testing unit. Ensure cold chain of custody is maintained.
∙ Performs identification tagging for raw materials within the Building 38 warehouse and associated off site warehouse locations.
∙ Attends and contributes to scheduled team meetings, department meetings, and safety meetings. Performs document and procedure review as needed. Trains on departmental training modules as assigned. Pursues professional and or technical development training on/off site as assigned.
∙ Understand and support implementation of change controls, CAPAs, and deviation corrective actions. Notifies lab manager of any deviations or issues and initiates deviation investigations as required. Supports deviation investigations as necessary.
BA/BS in life sciences desired, some college coursework preferred. A minimum of 1 – 3 years of relevant experience in a cGMP controlled/pharmaceutical industry.
Excellent organizational, written, interpersonal, leadership and teamwork abilities. Excellent working knowledge of cGMPs (US, Canada, Japan, Europe). Experience in SAP, LabWare, Trackwise, Forklift Certification, and Aseptic Technique is beneficial.