Stability Scientist

Description

The Chemist is responsible for the coordination and organization of stability or reference standard studies to ensure uninterrupted daily operations associated with procurement, dispensing, studying, analyzing, and reporting of those studies while assuring compliance for Stability and Reference Standard Operations. This person will interface with various groups to request samples, resolve issues, and/or implement new studies.

• Provide timely stability services to ensure required studies are initiated according to filing strategies, and the needs of the business operations.
•  This includes ensuring stability protocols are written, material is obtained for studies and placed in chambers in a timely manner.
• Revise studies as required to ensure no interruption or exceptions to protocols result, which includes loading, reviewing, and verifying static tables to ensure accuracy
• Review, analyze and trend results to detect potential significant negative or aberrant results or trends.
•  Communicate concerns with management, customers, product quality, and laboratory personnel to ensure appropriate actions are taken and exception reports initiated.
•  Compile clear and concise graphical and tabular data summaries.
• Author, review and approve change control documents.