About Us
At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately,challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing "Health in Your Hands".
Sanofi Consumer Healthcare US (formerly Chattem) is a leading marketer and manufacturer of a broad portfolio of branded over-the-counter (OTC) healthcare products, in such categories as allergy, upper and lower gastrointestinal, skin care, topical pain care, oral care and other OTC toiletry products. The US CHC portfolio includes well-recognized brands such as: Allegra, Nasacort, Xyzal, Dulcolax, Gold Bond, Cortizone-10, Icy Hot, Aspercreme, ACT, Unisom, and Selsun Blue.
To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world.
Position Summary
This position is responsible for various aspects of the Stability program to include the organization of samples and documentation related to room temperature stability program to the completion of the end-to-end annual product review (APR) process and documentation.
The role includes storage of samples, examination of samples, and monitoring of storage conditions. The role 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.
This position will prepare APRs for internal as well as external (contract manufactured) products. This role 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.
Position Responsibilities
Stability Program Technician II duties fall under the scope of any data or documentation that relates to the room temperature stability process to include annual product reviews.
Management of room-temperature stability samples and documentation.
Management of the stability computer software where all stability data is maintained.
Collection and delivery of monthly room temperature stability samples to the appropriate labs.
Management of the retain sample collection and storage.
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.
Maintains the OOT spreadsheet based off APR data.
Assist with Novatek registrations, protocols, inventories, and data entry.
Serves as back-up 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)
Interfaces
CMOs
External Manufacturing
Procurement
Project Management
Quality Assurance
Quality Control (Analytical and Microbiology)
CHC Research and Development
Analytical Research and Development
Analytical Quality Assurance
Complaints
Supply Chain
Production Quality
Production Planning
Competencies
Must be organized and detail oriented
Project management
Technical writing
Statistical Analysis
Ability to adapt to a changing environment and adjust flexibly
Strong verbal and written communication skills required
This description is representative but not inclusive of all position responsibilities. Associate may be asked to complete tasks not listed within the contents of this document, but that are relative to the goals of the business.
Job Requirements
Education:
Bachelors. Degree in Chemistry or closely related field, preferred
If degree is not met, 5-10years of GMP experience required
Experience:
5+ years of GMP related experience or equivalent
Professional Skills:
Basic computer skills, technical writing skills, project management, strong verbal and written communication skills, statistical analysis skills
Role Specific Competencies:
Must have a demonstrated proficiency in Microsoft business software including Excel, Word, and Outlook.
Desired Qualifications
Experience using SAP and Novatech
Previous Pharmaceutical experience
What's In It For You
Competitive Pay
Three (3) Weeks Paid Vacation
Robust 401(k) + Employer Match
Health, Dental, Vision Insurance
Tuition Reimbursement
Parental Leave
Learning and Developmental Opportunities
Employee Resource Groups
EEO/AA Employer:Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, or protected veteran status.
Location:Chattanooga, TN, USA
Relocation:Relocation assistance is not available.
Travel:Out of town travel not required.
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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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.