What are the responsibilities and job description for the Stability Data Analyst III position at Sanofi?
Job title: Stability Data Analyst III
Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.
We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet. That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.
This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. Join us on our mission. Health. In your hands.
The Stability Data Analyst III is responsible for the completion of the end-to-end annual product review (APR) process and documentation. This includes APRs for internal as well as external (contract-manufactured) products. The Stability Data Analyst III will review the APR Database including data entries and/or various other critical documentation related to the function. This position helps ensure the maintenance of stability data and release data and uses that data to manage the creation of the annual product reviews. The Stability Data Analyst III provides support in specification lifecycle management (including purchasing specifications for contract manufacturing organizations) as assigned. In addition, this position also supports any duties of Stability Specialist I or II roles as needed.
Main Responsibilities
- Location: Onsite in Chattanooga, TN
Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.
We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet. That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.
This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. Join us on our mission. Health. In your hands.
The Stability Data Analyst III is responsible for the completion of the end-to-end annual product review (APR) process and documentation. This includes APRs for internal as well as external (contract-manufactured) products. The Stability Data Analyst III will review the APR Database including data entries and/or various other critical documentation related to the function. This position helps ensure the maintenance of stability data and release data and uses that data to manage the creation of the annual product reviews. The Stability Data Analyst III provides support in specification lifecycle management (including purchasing specifications for contract manufacturing organizations) as assigned. In addition, this position also supports any duties of Stability Specialist I or II roles as needed.
Main Responsibilities
- Review data entered into the APR database to ensure adherence to the program
- Collection of all required documentation from responsible departments or contract manufacturing organizations to ensure timely completion of APRs
- Management of stability data for NDA products sent externally for annual reports
- Perform statistical analysis of data using Microsoft Excel or Minitab (or other approved statistical software program)
- Author, route, and appropriately file all APRs
- Development and maintenance of the APR schedules
- Author report for the annual visual inspection program
- Serves as backup and support to Stability Specialist I and II roles (stability and retain sample management including Novatek entry and review)
- Supports supervisor with other department-related duties as assigned (e.g. - specification lifecycle management)
- Education: B.S. Degree in Chemistry or closely related field.
- Experience: 5 years of GMP-related experience or equivalent preferred.
- This position requires extensive use of computer equipment. Must have a demonstrated proficiency in Microsoft business software including Excel, Word, and Outlook. Basic computer skills, technical writing skills, project management, strong verbal and written communication skills, and statistical analysis skills. Capable of prioritizing tasks to meet goals and ensure product quality.
- Knowledge of Good Manufacturing Practices
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs and at least 14 weeks’ gender-neutral parental leave.
