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Sanofi Group Quality Control Analyst I 2nd Shift in Allston, Massachusetts

Position Overview:

Quality Control Microbiology Department supports manufacturing activities at Genzyme Allston Landing 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.

Key responsibilities may differ among employees with the same job title and may change over time in accordance with business needs. This individual will report to the QC shift Supervisor in the Allston Quality Control laboratory and will contribute to general operations and testing of the QC.

Shift: 2nd shift Tue-Friday 1:00PM-11:30PM

Key Responsibilities:

  • Collect and process samples in a timely manner, microbiological routine testing of raw materials, in-process, validation samples and final products in accordance with SOPs and CGMP regulations; 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 Environmental Monitoring.

  • Perform Endotoxin Testing (LAL Gel-Clot and Kinetic Turbidimetric).

  • Perform Bioburden Testing of In-process products, buffers, and water.

  • Receipt of manufacturing samples into the QC lab as well as sample retain disposal.

  • Autoclave QC micro equipment.

  • 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.

  • Assist in the development and optimization of testing methods.

  • 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 and perform special studies & projects assigned to microbiology.

Basic Qualifications:

  • Bachelor’s Degree in Life Science discipline.

  • No prior industry experience required.

  • Knowledge of Microsoft Office.

Preferred Qualifications:

  • 1 Year Experience in a CGMP lab environment.

  • Proficient in Outlook, MS Word, Excel and lab based data management systems.

  • Experience with environmental monitoring including water testing.

Special Working Conditions:

  • Must be able to lift 40 lbs.

  • Must be able to gown and gain entry to manufacturing areas.

  • Must be able to work with Spor-Klenz solution, which is used to sanitize equipment.

  • Must be able to work on flexible schedule on periodic basis based on business need.

  • Position is considered essential personnel and may be required to staff the lab during inclement weather events.

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.

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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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