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?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
THE FINE PRINT
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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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$26.32 - $35.09All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.