Sanofi Group Quality Technician - Vaccine in Swiftwater, Pennsylvania
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.
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.
Processes and inspects product samples from contract manufacturers.
Ensures cold chain of custody is kept on samples and samples are distributed to the applicable testing unit.
Ensures cold chain of custody is maintained.
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 product released by PQ Batch Release.
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.
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.
BA/BS in life sciences 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, EDMS, Trackwise, Aseptic Technique is beneficial.
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.
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.