Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job Title: Quality Control Analyst I

Location: Framingham, MA

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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.

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.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Perform laboratory assays in support of Method Development, Product Release, and stability.

• Troubleshoot assay and Instrument problems with departmental leads.

• Review data for compliance to procedures and specifications.

• Calculate and evaluate results.

• Successful completion of assigned training.

• Make detailed observations in support of Alert, Action and OOS result investigations.

• Participate in writing and revising SOP’s.

• Ensure lab areas are clean, safe and properly stocked.

• Effectively demonstrate an understanding of cGMPs and application to specific

• Work compliantly & independently under supervision and direction.

• Follow accurate written procedures for testing of in-process and final product samples.

• Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines.

• Perform maintenance on basic laboratory equipment.

* Key Responsibilities may differ among employees with the same with the same job title and maychange over time, in accordance with business needs

About You

Basic Qualifications:

One of the following:

• High School Diploma with minimum of 4 Years of relevant industry experience.

• Associates Degree with 2-4 Years of relevant industry experience.

• Bachelor’s Degree with 0-2 Years of relevant industry experience.

• Proficient with Microsoft Office tools such as: Word, Excel & Powerpoint.

Preferred Qualifications:

• 1 Year Experience in GMP lab environment.

• Proficiency in Microsoft Office tools such as: Word, Excel & Powerpoint.

• Experience with lab based data management systems.

• Experience in a Quality Control Laboratory.

• Experience with Environmental Monitoring, including Water Testing.

Special Working Conditions:

• Work in a laboratory with minimal use of chemicals.

• Ability to lift 10 lbs.

Why Choose Us?

• For influenza production roles (excluding FFIP roles): candidate must be able to be receive influenza vaccine which is required for building access​

• For aseptic area production roles (excluding Flu production tech roles): candidate must be able to obtain and maintain current aseptic gowning qualification​

• This position may be required to be moved or temporarily flexed to another department or building within the FFIP operation due to business needs. Additionally, candidates should expect to work in multiple buildings. Some over-time/off-shift work hours may be required based on business needs. We will attempt to provide as much advance notice as possible, two weeks where applicable if any such change is needed.​

• Must be able to lift up to 25 lbs., and bend/lift/move objects as part of the job.​

• Able to stand for up to 8 hours a day (with occasional breaks)

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.