35% - Support stability program activities by ensuring studies are initiated per timelines, stability pulls and test requirements are accurate and complete, and pull dashboards are prepared per schedule.
35% - Initiate test requests, follow through with testing labs for on-schedule reporting of the test results, draft time point reports, and archive data.
10% - Maintain an accurate inventory of stability samples.
10 % - Assist in developing/maintaining relevant procedures and systems.
5% - Escalates unusual observations or incidents of non-compliance.
5% - Seek out and perform process improvements.
Education and Experience Requirements
- Minimum, BS or MS degree in chemistry, biology, biotechnology, or related field.
- 3-5 years of industry experience with quality functions: quality control, manufacturing, or project management.
- General knowledge of ICH guidelines for stability.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.