Duties and Responsibilities:
1. Initiate stability testing of all OTC and Cosmetic products with Project Manager and/or customers. (As well as interface with customers to understand product families)
2. Run reports to identify qualifying SKUS as well as production dates.
3. Complete NSSR (nonstandard sample request) forms so the necessary samples are pulled from production.
4. Review samples to ensure they meet quality standards.
5. Ship stability samples to the appropriate stability testing facility per internal and customer requirements.
6. Fluent in Microsoft (Word and Excel)
7. Maintain records of all stability-related and sample retain activities.
8. Generate stability protocols at the onset of all Marketed Product Stability studies and coordinate with Project Managers and customers in getting protocols approved for study initiation.
9. Monitors “Time-In” stability logs to ensure that all stability data is being reported in a timely manner.
10. Coordinate with stability testing facility, Analytical, Microbiology & R&D Managers the testing of stability samples and timely reporting of data.
11. Final review of stability C of A’s that are reported to the customer prior to results being submitted.
12. Report any OOS or OOT results to Regulatory Manager.
13. Perform and document Annual Drug Product Reviews for OTC products.
14. Perform and document visual annual product reviews on retain samples.
15. Coordinate results of Annual Drug Product Reviews with Customers.
16. Special projects as needed.
17. Track costs as needed. i.e. shipping, outside testing etc.
Physical Requirements:
The candidate successfully filling this role will have the ability to move frequently, often traversing from computer or desk work to review filed documents. Ability to lift up to 25 pounds.