Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

Job Summary

Role Specific Responsibilities

• Manage the collection and review of manufacturing documentation and physical samples for raw material evaluation and supplier projects to support life cycle management.

• Generate and maintain the raw material laboratory specifications and / or purchasing specifications.

• Execute change requests for the raw material suppliers and / or specifications to support life cycle management.

• Prepare and maintain risk assessments, performance assessments, and quality agreements for CMO's and raw material suppliers.

• Participate in the evaluation process of potential new suppliers and providers.

• Assist in resolution of quality issues relating to raw materials used at the Chattanooga site or relating to products produced by CMO’s and suppliers.

• Provide support to the supplier quality team to maintain the annual Approved Supplier List.

Interfaces

• Quality Control

• Procurement

• Analytical Research and Development

• CHC Research and Development

• External Manufacturing

• Operation

• Raw Material Manufactures & Vendors

Competencies:

• Analytical Experience

• Communication

• Technical Writing

• Experience with cGMP Quality Systems

• SAP experience

This description is representative, but not inclusive of all position responsibilities. Associate may be asked from time to time to complete tasks not listed within the contents of this document, but that are relative to the goals of the business.

Education: Bachelor’s degree required. Chemistry, Pharmaceutical Sciences, or closely related field preferred.

Experience: Minimum of 2-3 years laboratory experience and/or experience in Quality Assurance preferred.

Professional Skills:

• Self-motivated, detail oriented, along with good organizational skills. This position requires extensive use of computer equipment.

• Must have a demonstrated proficiency in Microsoft business software to include Excel, Word, and Outlook.

• Strong verbal and written communication skills are required.

Role Specific Competencies: Knowledge of FDA cGMP regulations

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.

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#LI-SA

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.