Sanofi Group Quality Control Analyst II - Framingham, MA in Framingham, Massachusetts
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.
This Quality Control Analyst II 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.
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 Sanofi's safety procedures and guidelines
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 1year experience in cGMP lab environment
Proficient in Outlook and Microsoft Word and Excel and lab based data management systems
Experience with Dionex, GC, HPLC, Gel Electrophoresis, UV Vis Spectroscopy and wet Chemistry Knowledge
Experience with Empower software
Knowledge of lab-based data management systems
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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