QC Analyst, Environmental Monitoring — GMP Lab

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

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.