Quality Control Analyst

Sanofi•Framingham, MA

3d•Onsite

About The Position

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 and projects. 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.

Requirements

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.

Nice To Haves

Experience in GMP lab environment.
Experience with lab based data management systems.
Experience in a quality control lab.

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.