Quality Technician - Vaccine

QUALITY TECHNICIAN - VACCINE This position will perform Quality inspections on incoming material inspections, documentation verification, statistical sample removal, and status 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. KEY ACCOUNTABILITIES 50% - 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. 10% - 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. 10% - Processes and inspects product samples from contract manufacturers. Ensures a cold chain of custody is kept on samples and samples are distributed to the applicable testing unit. Ensures a cold chain of custody is maintained. 10% - Performs status tagging for raw materials within the Building 38 warehouse and associated off-site warehouse locations. Performs status tagging for intermediates, final bulks, final containers, and finished products released by PQ Batch Release. 10% - 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. 10% - Understand and support the 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. Each individual working in a GMP area is responsible for following the documented processes and recording GMP data correctly. Non-compliance in following a GMP process or procedure may result in regulatory observations, up to and including recall, and a significant risk to the site’s continued operation. Attention to detail in recording GMP data right the first time into GXP documents. The ability to handle multiple priorities (and respect timelines) is required in order to surpass milestones. The ability to negotiate, work with and influence a variety of people in a positive manner while identifying, and working to solve problems is a requirement of the position. The incumbent must be able to work effectively with colleagues at other Sanofi, contract sites, and outside vendors to ensure that GMP data is available in a timely manner. Physical working conditions include lifting up to 50lbs, Forklift Certification The position may require that the incumbent interacts with external customers as a representative of Quality Operations. External companies include raw material vendors and other Sanofi sites on a global level. The incumbent must process raw material batches to ensure timely disposition within agreed-upon timelines to support production scheduling and or marketing expectations. The incumbent must work within the policies, procedures, and regulations as required by the Company and under the Occupational Health and Safety Act. BASIC QUALIFICATIONS: BA/BS in life sciences required A minimum of 3 – 5 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, EDMS, Trackwise, and Aseptic Technique is beneficial. Forklift Certification preferred. As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities. According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.