Sanofi Group Quality Technician in Swiftwater, Pennsylvania
The Quality Technician - Quality Control will perform QC testing by strictly adhering to Sanofi Pasteur policies and procedures and cGMP to provide multi-site investigational support throughout the product lifecycle as well as product release testing. The candidate filling this position will work to ensure assays are completed in a timely compliant manner. 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 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 (Release and Investigational) as per testing schedule defined by laboratory management to meet demands of Production, Methods Development, Validation, Independent Demand, Stability program, and Post-Market Quality Monitoring.
Operation and data interpretation using the following analytical equipment: Fourier Transform Infrared Spectroscopy (FTIR), Scanning Electron Microscopy and Energy-Dispersive X-Ray Spectroscopy (SEM-EDS), various Optical Microscopes and Cameras, Plate Readers, Mechanical Testing Equipment, Liquid Particle Counters, etc.
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.
Ability to work in fast paced environment with changing priorities.
Performs peer proofing on assays.
Proficiency in working in Microsoft 365 programs such as Word and Excel, and Technical Writing.
Maintains laboratories in a safe and compliant state.
Performs system related functions: SAP (Cycle counts, confirmations, inventories, etc.), LIMS (inventories, chain of custody, GMP data, etc.), Labwatch, etc.
Performs cleaning of laboratories, equipment, and ancillary areas as required.
Attends/Contributes to scheduled team meetings, department meetings, and safety meetings.
Safety and compliance training.
Module/Assay training as assigned.
Professional/Technical development training on/off-site as assigned.
Understand and support implementation of Change controls, CAPAs, and other related processes.
Notifies laboratory manager of any deviations or issues and initiates incident investigations as required.
Support deviation investigations.
All other duties as assigned.
BA/BS in life sciences or Associate’s Degree in life sciences with 2+ years’ experience, or 8+ years relevant experience.
A minimum of 2 years of relevant experience in a cGMP controlled/pharmaceutical industry is desired.
Attention to detail in recording GMP data right 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 and contract sites, as well as outside vendors to ensure that GMP data is available in a timely manner.
Vaccinations may be required and 20/20 vision with corrective eyewear required
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.