Sanofi Group Quality Control Scientist I in Ridgefield, New Jersey
Quality Control Scientist I
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 raw material, intermediate and final product samples to demonstrate that all products meet all specifications and standards required for cGMP operations. Various techniques are utilized in Quality Control including HPLC, GC, and multiple types of spectrophotometry. Additional functions include stability testing, assay transfers, method validation and the qualification of new instrumentation utilized in the Quality Control laboratory.
POSITION OVERVIEW/KEY RESPONSIBILTIES\
This position is responsible for performing routine and complex techniques associated with daily QC use. It provides an in-depth investigative and technological orientation in implementing, executing and interpreting quality procedures. Successful candidate will substantially contribute to process and method improvements within the Quality Control laboratory.
Perform routine analysis on complex laboratory equipment including HPLC and GC systems.
Participate in training of less experienced staff on new technology.
Qualify and implement new equipment and technology to the QC laboratory.
Develop and author complex and explicit documentation for new and current procedures and technical reports.
Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.
Provide technical leadership and guidance for the successful completion of major laboratory projects:
Implement new quality control procedures.
Identify deviations from QC methods and develop appropriate CAPAs.
Recommend laboratory and equipment-related improvements.
Work effectively with others to achieve shared goals and meet timelines.
Interact with internal and external personnel on technical matters requiring
coordination between sites.
Work independently with minimal to no supervision and direction.
Handle OOS investigations for testing
Work in compliance with cGMPs.
- Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
- Bachelor’s degree in Life Sciences discipline and 8 years of experience in CGMP lab environment, or Master’s degree in Life Sciences discipline and 6 years’ experience in CGMP lab Environment.
Proficient in Microsoft Office; Empower data system and lab based data management systems.
Ability to present technical data.
Ability to work independently on scientific projects.
Familiarity with USP and global compendia regulations.
Scientific technical writing ability including authoring and revising SOPs, validation protocols and technical reports.
Experience troubleshooting of assay and equipment issues.
Experience with ELISA test procedures.
Supervisory experience in QC laboratory setting
Project Management experience to manage projects throughout the lifecycle including identifying and meeting key milestones.
SPECIAL WORKING CONDITIONS:
Occasional nights, weekends and holidays may be required.
Some travel may be required.
Job: Laboratory/Process/Device Development
Primary Location: United States-New Jersey-Ridgefield
Job Posting: Dec 1, 2016, 9:28:10 AM
Job Type: Regular
Employee Status: Regular