Quality Control Analyst

Sanofi; Framingham (MA); On-site; USD 57,000 - 76,000; Full time

Benefits offered by this job

High-quality healthcare

Prevention & wellness programs

14 weeks gender-neutral parental leave

Job summary

Sanofi Framingham seeks a Quality Control Analyst to perform routine and complex testing of in-process samples and final products in a CGMP environment. You will contribute to method development, qualification, validation, and investigations while ensuring data quality and compliance.

Ideal candidates have a Bachelor’s degree (or Master’s) with relevant lab experience, and proficiency with common Office tools.

Qualifications

• Bachelor’s degree or equivalent and 2+ years laboratory experience or Master’s with 0-1 year experience.
• Basic knowledge in Bioburden, TOC, Endotoxin, Water Chemistry, ELISA preferred.
• Proficient with Microsoft Office (Word, Excel, PowerPoint).
• Proficient with Microsoft Office tools such as Word, Excel & Powerpoint.

Responsibilities

• Perform routine and complex laboratory assays in support of method development, qualification, validation, and product release.
• Maintain and calibrate complex laboratory equipment and ensure data integrity.
• Review data for compliance with SOPs and specifications; document observations and investigations.
• Assist in SOP writing and qualification of new controls, standards, and reagents.
• Make detailed observations in support of Alert, Action and OOS result investigations.
• Participate in writing and revising SOPs.
• Assist in the qualification of new controls, standards and reagents.
• Ensure compliance with CGMPs and safety procedures.
• Participate in problem solving meetings and suggest process improvements.
• Independently work under supervision and direction.

Skills

Laboratory testing

CGMP compliance

Documentation

Education

Bachelor’s degree or equivalent

Master’s degree or equivalent

Tools

MS Office

Job description

**Job title:** Quality Control Analyst**Location:** Framingham, MA**Shift:** Sun-Wed 10am-8:30pm **About the job**Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In 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 andprojects. **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. **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. **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. **Preferred Qualifications:*** Experience in GMP lab environment.* Experience with lab based data management systems.* Experience in a quality control lab. **Special Working Conditions:*** Work in a laboratory with minimal use of chemicals.* Ability to lift 10 lbs. All or part of the information contained in this document should be treated as the property of Sanofi or its affiliates. It cannot be published or divulged for whatever purpose to any third party, unless an appropriate non-disclosure agreement has been signed by the third party and prior approval is obtained from the Sanofi function owning this document. Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.**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.Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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#LI-Onsite#vhd# Pursue *progress*, discover *extraordinary*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.Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here*US and Puerto Rico Residents Only*Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.*North America Applicants Only*The salary range for this position is:$27.24 - $36.32 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.