Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
Health & Wellness
Comprehensive coverage including medical, dental, vision, and health and wellness programs.
Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.
At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.
Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.
"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic
"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."Suncére Hernandez Area Business Manager, Multiple Sclerosis
"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."Bob Shustack Head of Global Support Functions Finance, North America
**Hours could be one of the following shifts. Hours include flexibility, over-time, holidays and/or weekends if needed**
Monday- Friday- 8am-4:30pm
This position supports the execution of routine testing in the Quality Control Bioassay laboratory while strictly adhering to site work instructions, Federal Regulations, cGMP, and Sanofi Pasteur policies and procedures. This position requires the individual to perform route testing as scheduled to support production, method validation as well as the stability program and completing required documentation.
- Knowledge of general Immunological techniques including ELISA and immunodiffusion based assays.
- Demonstrated knowledge and proficiency of functions within the following systems are required: SAP, Trackwise/Phenix, LIMS, and eDoc/Geode+.
- Activities include: assist with maintaining safety and compliance of the laboratory work area; Perform cleaning of laboratories, equipment, and ancillary areas as required; Attend/Contribute to scheduled team meetings, department, and safety meetings.
- This position requires proficiency and understanding of the theory related to processes, assays, and equipment as well as the ability to identify issues/trends.
- Participates in training activities including their individual professional development, creation/revision of training modules as well as provide training to others on processes, procedures, assays, and equipment with which they are proficient.
- Demonstrate proficiency in use and knowledge of change controls, CAPAs, and the QA deviation system.
- Perform initial deviation investigations through analyst interview.
- Develop a working knowledge of appropriate compendia and/or regulatory guidance.
- Performs current tests by strictly adhering to SOP, SWI, Federal Regulations, cGMP, training modules (when applicable), Sanofi Pasteur policies and procedures and safety procedures.
- Performs testing as per testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand and Stability program.
- Completes required paperwork and documentation as required.
- Ensures product integrity by testing products, pulling samples, placing work orders and visual inspection of samples.
- Prepares for and operates QC equipment including pre and post run setup and maintenance. Troubleshoots sample discrepancies.
- Performs peer proofing on assays.
- Maintains laboratories in a safe and compliant state.
- System-related functions: SAP (Cycle counts, confirmations, inventories, etc.), Trackwise (MDOs & IPDNs), LIMs (inventories), etc.
- Performs cleaning of laboratories, equipment, and ancillary areas as required.
- Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.
- Document review.
- Safety and compliance training.
- Module/Assay training as assigned.
- Professional/Technical development training on/ off-site as assigned.
- Understand and support the implementation of Change controls, CAPAs, and deviation corrective actions.
- Notifies laboratory manager of any deviations or issues and initiates incident investigations as required.
- Support deviations.
All other duties as assigned
- 4 years' science degree ( Biology, Immunology and related disciplines)
- 1 - 3 years of relevant experience (immunology, biology).
- Good mathematical skills and computer literacy.
- Excellent organizational, verbal communication, and written communication skills.
- Ability to work efficiently with minimal error and high attention to detail.
- Experience directly working in a cGMP facility, including QC testing is preferred.
- Prior Quality Control experience desirable.
- Knowledge of immunological techniques that include ELISA, HAI (Hemagglutinin inhibition) and immunodiffusion techniques.
- Exceptional attention to detail and strong writing skills are crucial.
- Individual must be familiar with cGMP guidelines.
- Candidate must be able to work in a team environment.
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.
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