We are currently seeking a Stability Program Coordinator! The Stability Program Coordinator will coordinate all work processes associated with the Product Stability Programs including organizing the Stability Study Design with the client and ensuring test scheduling is executed in house or at third party contract laboratories according to the respective stability protocols.
About the Role:
- Ensure and manage the stability samples which includes initiation of the study with a stability; initiation form, generation of a stability protocol and register the study, stability sample inventory, sample labeling, stability data summary reports, and data evaluation
- Ensure that all samples are pulled on time and maintained monthly schedule
- Inter-department coordination for sending samples to contract laboratories for testing
- Coordination with various departments including Quality Control Release testing teams (QC), Quality Assurance (QA), and Research Grade (RG) about stability testing
- Create master stability log, maintain and reject stability data and trend stability data and send data for offsite storage
- Maintain stability database; proactively address any areas for system improvements
- Write, review, and auditing SOPs, Stability Protocols and Reports
- Ensure all stability activities are in accordance with SOP's and cGMP
- Bachelor's degree in Chemistry, Biology or related sciences
- Minimum of 2 years of relevant experience in a pharmaceutical testing laboratory
- Experience and understanding of ICH stability guidelines
Why Join Aldevron?
- You want meaningful work. We are in a landmark moment in the history of life science, and Aldevron is at the center of it.
- You want to plant your career in a growing company. We are growing fast. We have limitless opportunities for people who are ready to roll up their sleeves and jump in.
- You are excited to learn every day. At Aldevron, no day is the same. Our team comes to work ready to learn and overcome new challenges with teamwork and a passion to make lives better
Your talents, ideas, and passion are essential to our success. Join us today!