Sanofi Group QC Analyst II- Rotating Day shift in Framingham, Massachusetts
QC Analyst II- Rotating Day shift
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) 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.
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
PLEASE NOTE12 hour rotating day shift- every other weekend incorporated into schedule.
This position is responsible for performing routine to complex techniques associated with daily QC release and provide an investigative or technological orientation in implementing, executing and interpreting quality procedures and test methods.
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.
Investigate and troubleshoot Quality Control methods.
Prepare investigations related to OOS/OOT results.
Review of QC Data for compliance to procedures and specifications.
Prepare statistical analysis of results.
Participate in training of less experienced staff on new procedures.
Transfer methods from support groups to the QC laboratory.
Develop and author complex and explicit documentation for new and current procedures and technical reports.
Provide technical leadership and guidance for the successful completion of major laboratory projects:
- Implement new quality control procedures
- Transfer and develop new methods
- Identify deviations from QC methods
- Recommend method improvements
- Implement and monitor personnel training
Work effectively with others to achieve shared goals
Interact with external personnel on technical matters requiring coordination between sites
Work independently with minimal supervision
Work in compliance with cGMPs
Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.
B.A. or B.S degree in life or physical sciences and 2 years experience in a cGMP lab environment or M.S. degree in life or physical sciences and 1 year experience in a cGMP lab environment.
Experience using Dionex, GC, HPLC, Gel Electrophoresis, UV/VIS Spectroscopy, and wet Chemistry.
Experience with Empower software.
Knowledge of lab-based data management systems.
Primary Location: United States-Massachusetts-Framingham
Job Posting: Sep 27, 2016, 11:58:27 AM
Job Type: Regular
Employee Status: Regular