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Quality Control Anayst I

Expired Job

Sanofi Framingham , MA 01702

Posted 4 months ago

Department Description:

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.

Position Overview/Key Responsibilities

Position Summary

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

Core Responsibilities

  • 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 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

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

  • Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures

  • Being honest and treating people with respect and courtesy

  • Constantly striving to make Sanofi a great place to work, and a company respected for the quality of its people and products

  • Acting as a role model for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs

Basic Qualifications:

  • Associates degree in a related discipline and minimum of 0-2 years of industry experience or Bachelor's degree in Life Sciences discipline

  • Working knowledge of Aseptic practices and technique

Preferred Qualifications:

  • 1 year experience in a cGMP lab environment

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

Special Working Conditions:

  • Must be able to lift 40lbs

  • Must be able to gown and gain entry to manufacturing areas (clean room)

  • Occasional nights, weekends and holidays may be 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.

#GD-SG

#LI-GZ

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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Quality Control Anayst I

Expired Job

Sanofi