Stability Associate II

Job description

Shift Schedule Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope: Responsible for maintaining the following systems and/or databases: Stability System II Software, stability database, stability variances, stability environmental chambers, assistance in writing stability protocols and reports, data auditing and stability records. Essential Duties & Responsibilities: - Requisition, label and place stability samples into appropriate storage conditions according to approved protocols. - Enter new lots into the Stability System II Software and stability databases. - Pull samples at appropriate time points and deliver to the QC, AD and Microbiology Labs, as appropriate. - Monitor chamber storage conditions per electronic monitoring systems and follow-up on any excursions. Audit stability data after data entry for accuracy & compliance to protocols. - Review stability data to monitor product performance. Ensure that variances, aberrant results and incident reports are documented. - Print graphs and data as required for investigations. - Write stability protocols and reports for regulatory submissions. - Accurately process Document Change Requests (DCR’s) and Product Change Orders (PCO’...