About the job
POSITION SUMMARY:
As a Stability Scientist, you will play a vital role in supporting the Quality Control Stability program in Syracuse. This entails administering stability studies that are crucial for site manufacturing, as well as overseeing stability programs for other locations and Third Party Manufacturers (TPMs).
Duties/Responsibilities:
1. Assist in program administration by managing a schedule of pull dates for testing, preparing for, or overseeing sample pulls as required by the timeline.
2. Draft study protocols and aid in the management of study programs as needed.
3. Monitor and evaluate stability data, generate pull data reports post-testing, and prepare trend graphs; conduct data verification and report any unusual trends to management for evaluation.
4. Provide Stability LIMS Administration Support for the department, including study administration, maintenance, and training.
5. Support the operations of the Stability and Reserve Sample Facility, including unit maintenance, inventory control, sample receipt and destruction, sample pulls, and deliveries.
6. Ensure compliance with training requirements.
7. Author and/or update GMP documents.
8. Maintain the office and stability facility in compliance with cGMP standards.
9. Initiate and advocate for changes as part of operational excellence.

