Description

Reporting to Stability Coordinator, the Stability Support Specialist will primarily review draft stability protocols, generate or review data tables, and assist in setting stability studies. 

• Review draft stability study protocols for accuracy and completeness. 

• Track stability study pull due dates and pull all necessary samples for submission to testing personnel within the required timeframe. 

• Maintain stability chamber inventories. 

• Consolidate and transcribe information into data tables at the conclusion of each testing timepoint. 

• Review stability data tables generated by other department personnel for accuracy and completeness. 

• Assist the Stability Coordinator with setting stability studies (aliquoting materials, preparing labels, preparing containers, etc.). 

• Dispose of unused stability materials at the conclusion or cancelation of a study. 

• Perform stability chamber temperature mapping. 

• Assist with quarterly CS stability inventory.  

• Support the Stability Coordinator with any other department related tasks as appropriate.  
• All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures.  All employees are expected to report to work regularly and promptly.  Other duties relating to departmental mission, not specifically detailed in this section may be assigned. 

• cGMP knowledge required  
• High attention to detail 

• Proficiency in a windows-based environment including word processing, spreadsheet and database programs 

• Experience with chemical handling preferred 

High school degree or GED required 

Experience with chemical handling preferred 

cGMP knowledge required  

PI283733084