Sanofi Group Quality Specialist US Release in Atlanta, Georgia
Job Title: Quality Specialist US Release
Perform final batch disposition for all products in a US pharmaceutical distribution facility. Review associated batch documentation for compliance to cGMPs and Sanofi Standard Operating Procedures (SOPs).
Maintain batch status for all products in validated inventory system within the U.S. Distribution Center network.
Communicate issues contributing to batch release delays in a timely manner to affected parties (Supply Chain, Customer Service, etc.). Maintain both internal and external customer service expectations with clear, concise communication and sense of urgency.
Interact with manufacturing quality sites and internal functional units for resolution of quality issues or potential quality issues.
Develop, review and update Standard Operating Procedures (SOPs) relating to batch release activities.
Train and support other functional units on applicable quality systems and processes.
Support product launch activities as required, with execution of product launch checklist, verification of product labeling, change control verification, etc.
Support and lead projects as assigned that impact product quality / site compliance.
Bachelor’s Degree, preferably in pharmaceutical orbusiness relatedfield. Equivalent experience will be considered in lieu of Bachelor's degree.
5+ years’ experience required in the pharmaceutical industry with specific experience incGMPs, Quality Assurance/Quality Control documentation and integrated management systems.
3+ year's experience required with SAP application or similar ERP system.
Experience required in anFDA regulatedarea working with complex documentation.
Strong working knowledge ofcGMPs, Change Control, SOPs, documented evidence and version control
Demonstrated ability to multi-task in a demanding and challenging work environment
Demonstrated competency with prioritization skills
Demonstrated ability with problem resolution
Technical writing skills
Ability to develop and sustain productive working relationships
Effective communication skills (oral and written) with a wide range of internal and external audiences
Ability to manage effectively in a demanding work environment
Have a background and/or good understanding of the distribution practices and methods of a US pharmaceutical distribution facility
Ability to travel up to 10%
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.