Overview In this role you will coordinate stability and reference standard studies to support uninterrupted daily operations across procurement, dispensing, studying, analyzing and reporting activities. You will collaborate with cross-functional groups to request samples, resolve issues, and implement new studies while ensuring compliance for Stability and Reference Standard Operations. You will manage protocols, material sourcing, and timely chamber placement, and you will revise studies to avoid protocol interruptions. You will analyze results, communicate findings to stakeholders, compile data summaries, and handle change control documentation. This position offers a chance to impact quality and N
Responsibilities- Provide timely stability services to initiate required studies according to filing strategies and business needs
- Ensure stability protocols are written and materials are obtained and placed in chambers promptly
- Revise studies to prevent interruptions, including loading, reviewing, and verifying static tables for accuracy
- Review, analyze, and trend results to detect significant negative or aberrant results or trends
- Communicate concerns with management, customers, product quality, and laboratory personnel to trigger appropriate actions and exception reports
- Compile clear and concise graphical and tabular data summaries
- Author, review and approve change control documents
Key requirements- communication
- cross-functional collaboration
- problem-solving
- stability studies
- protocol writing
- data analysis
