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Quality Control Microbiology supports manufacturing activities at Sanofi's Framingham Campus by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the different stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.
Contribute to general operations and testing of the QC Microbiological laboratory. Work independently under general supervision to conduct microbiological routine testing of environmental, critical utility, raw materials, in-process, validation samples and final products in accordance with SOPs and cGMP regulations. Review laboratory assay documentation for accuracy and timelines, evaluate preliminary results; aid in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties. Position will be on a rotating 12 hour shift 7AM-7PM.
Collect and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
Perform Water, Steam and Critical Utility collection as well as associated testing
Perform Biological Indicator Testing
Perform Endotoxin Testing (Gel-Clot and Kinetic)
Perform Bioburden Testing of in-process products, buffers, and water
Receipt of manufacturing samples into the QC lab as well as sample retain disposal
Troubleshoot assay and instrument problems with Laboratory Supervisor
Enter and review data in LIMS
Perform safety and operational lab audit
General maintenance of lab equipment
Participate in writing and revising SOPs, protocols
Maintain log books related to inventory and equipment
Ensure labs are clean and safe (in compliance with cGMP) and properly stocked
Make detailed observations in support of Alert , Action and OOS result investigations
Participate in the qualification of equipment, methods and processes
Participate in and perform special studies and projects assigned to QC Microbiology
Perform other additional job related duties as required
Perform ELISA testing
Provide training and technical leadership to less experienced staff
Participate in authoring complex ad explicit documentation
Involvement in equipment or facility qualifications (IQ, OQ, PQs)
Perform plate reading, streaking, gram staining, and microbial identification
Perform routine Quality Control testing of in-process and final products in a cGMP lab for release
Practice safe work habits and adhere to Sanofi's safety procedures and guidelines
Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
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