Quality Control Analyst

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* Job title:

** Quality Control Analyst
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* Location:

** Framingham, MA
** Shift:
** Sun-Wed 10am-8:30pm  
** About the job
** Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and  Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.  
** Department

Description:

** Quality Control Microbiology (QCM) is responsible for testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations. Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation. Quality Control is also responsible for assisting in site wide studies and projects.  
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* Position Summary:

** This position is responsible for performing routine and complex testing of in-process samples and final products in accordance with SOPs and relevant procedures for method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.  
** About Sanofi
** We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.  
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* Main Responsibilities:

*** Perform laboratory assays in support of method development, qualification, validation, method transfer, product release, stability, and process validation and investigations.
* Perform maintenance on complex laboratory equipment.
* Review data for compliance to procedures and specifications.
* Calculate and evaluate results.
* Make detailed observations in support of Alert, Action and OOS result investigations.
* Participate in writing and revising SOPs.
* Assists in the qualification of new controls, standards and reagents
* Effectively demonstrate an understanding of and work in compliance with CGMPs.
* Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines.
* Actively participate in problem solving meetings with senior staff members and suggest process improvements.
* Independently work under supervision and direction.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs  
** About you
**** 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:
* Being a Subject Matter Expert (SME)/Trainer/Coach to other analysts within the laboratory.
* Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products.
* Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.  
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* Basic Qualifications:

*** Bachelor’s degree or equivalent and 2 + years laboratory experience.
* Master’s degree or equivalent and 0-1 year experience.
* Basic knowledge (i.e. 1-2 years experience) in the required method platform (e.g. Bioburden, TOC, Endotoxin, Water Chemistry, ELISA).
* Attention to detail, and able to maintain accurate records with excellent proofreading skills
* Able to communicate effectively with others
* Able to work effectively both independently and as a member of a team
* Proficient with Microsoft Office tools such as:
Word, Excel & Powerpoint.  
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* Pre…