QC Analyst

Regulatory Toolkit; Framingham (MA); Sur place; USD 33 000 - 44 000; Plein temps

Résumé du poste

Sanofi in Framingham, MA is seeking a QC Analyst to join a GMP-focused laboratory team. The role involves collecting environmental monitoring and critical utility samples, performing tasks under cGMP and HSE guidelines, and ensuring data integrity.

You will review data, maintain instrument readiness, and participate in investigations when deviations occur, with a shift Sun-Wed 7:00 am–5:30 pm. US residents only.

Qualifications

• High School Diploma/GED with 4 years of industry experience.
• Associate Degree with 2–4 years of industry experience.
• Bachelor’s Degree with 0–2 years of industry experience.
• Proficient with Microsoft Office tools such as Word, Excel & PowerPoint.

Responsabilités

• Collect Environmental Monitoring (Viable Air, Viable Surface, Non-Viable Air Samples) and Critical Utility (RO, DI, WFI, Steam Water Samples, and Compressed Air and Mixed Gases Samples) in a timely manner, ensuring adherence to the committed scheduled plans.
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOS,) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

Connaissances

MS Office

Formation

High School Diploma/GED

Associate Degree

Bachelor’s Degree

Description du poste

Job title: QC Analyst

Location: Framingham, MA

Shift: Sun - Wed 07:00 am - 5:30 pm

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.

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:

• Collect Environmental Monitoring (Viable Air, Viable Surface, Non-Viable Air Samples) and Critical Utility (RO, DI, WFI, Steam Water Samples, and Compressed Air and Mixed Gases Samples) in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information related to his/her tasks, to comply with cGMP and data integrity requirements
• Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOS,) in a timely manner to ensure investigation and impact assessment are performed appropriately
• Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

Additional Accountabilities:

• Ability to perform tasks in a Quality Control Laboratory environment and capable of lifting at least 10 pounds. May be required to pass vision exam to perform specific responsibilities. May be required to enter into controlled environments following proper gowning protocols.

About You

Basic Qualifications:

• High School Diploma/GED with a minimum of 4 Years of any industry experience.
• Associate Degree with 2-4 Years of any industry experience.
• Bachelor’s Degree with 0-2 Years of any industry experience.
• Proficient with Microsoft Office tools such as Word, Excel & PowerPoint

Preferred Qualifications:

• 1 Year of Experience in a GMP lab environment.
• Experience with lab-based data management systems.
• Experience in a Quality Control Laboratory.

Special Working Conditions:

• Work in a laboratory with minimal use of chemicals
• Ability to lift at least 10lbs

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.

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.

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:

$24.00 - $32.00

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.