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Quality Control Anayst II Job at Quality at Sanofi

Primary Location Framingham, MA Job Category Quality Requisition Number R4995 Date posted 06/02/2017

This position is responsible for performing routine and complex testing of in-process samples, stability samples and final products in accordance with SOPs for product release and validation.

Quality Control Chemistry is responsible for testing intermediate and final product samples to demonstrate that all products meet all standards required for cGMP operations. Various techniques are utilized in Quality Control including HPLC, GC, Gel Electrophoresis and multiple types of spectrophotometry. Additional functions include stability testing, assay transfers and the qualification of new instrumentation utilized in the Quality Control laboratory.

Core Responsibilities

  • Perform UV-Vis spectrophotometry, HPLC and Gel assays for in-process and final product samples.
  • Perform maintenance on complex laboratory equipment including HPLC and GC systems.
  • Review of QC Data for compliance to procedures and specifications.
  • Calculate and evaluate results.
  • Participate in training of less experienced staff.
  • Transfer methods from support groups to the QC laboratory.
  • Author protocols and technical reports related to the implementation of QC equipment.
  • Effectively demonstrate an understanding of cGMPs and application to specific responsibilities:
  • Follow accurate written procedures for testing of in-process and final product samples.
  • Communicate inter-departmentally and with outside contacts to solve technical issues.
  • Exercise sound judgment and decision making when problem solving.
  • Revise standard operating procedures as needed.
  • Work independently under general supervision and direction.
  • Work in compliance with cGMPs.
  • Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines.

BASIC QUALIFICATIONS:

  • Bachelor’s Degree in Life Sciences discipline and 2 years experience in cGMP lab environment, or a Master’s Degree in Life Sciences discipline and 1 year experience in cGMP lab environment.
  • Proficient in Outlook and Microsoft Word and Excel  and lab based data management systems.

PREFERRED QUALIFICATIONS:

  • Experience with Dionex, GC, HPLC, Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry.
  • Experience with Empower software.
  • Knowledge of lab-based data management systems

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Primary Location Framingham, MA