Stability Coordinator

Job Description

The GQSS Stability Coordinator has a central role in managing all Stability programs managed through GQSS. The GQSS Stability Coordinator is responsible for the end-to-end Stability process within GQSS, starting from preparing the annual master plan for the involved products, coordinating the sampling and shipping with the sites in a timely manner, ensuring protocols are correct with the Contract Testing Labs, and overseeing the entry of the results into our Company systems. The GQSS Stability Coordinator also plays a key role in the assessment of the data, and the creation of the needed trend reports to scientifically show stability performance of the products. The GQSS Stability Coordinator acts as an SME and partner to various roles within and outside of GQSS involved in the Stability program flow, such as Contract Testing Labs oversight personnel, TCS Stability Analysts (GLIMS data entry), site planners, and Global Stability. 

This position reports to the Global Quality Shared Services Director or Associate Director Contract Testing Labs for general advice and instruction but can function independently.  

Primary Activities 

• Creation of annual Site Master List for all studies managed through GQSS, based on global stability protocols  
• SDS Requirement creation and maintenance based on master plan 
• Coordination of end-to-end stability process: coordinate study start dates with sites and lab within timeline requirements; communicate with manufacturing / packaging / testing sites 
• Review draft revisions of General Stability Protocols 
• Complete Impact Assessments and/or own tasks for stability related change controls 
• Review and approve Batch Specific Protocols 
• Approve timepoints and studies in GLIMS (or SPR) as needed 
• Act as SME for GLIMS template updates 
• Create Annual Summaries and trending as required (e.g., APR, Regulatory reporting); collect data, perform statistical trends, evaluate data and document in annual Stability Summary reports (by product, by strength, by manufacturing site); act as Second Person Reviewer 
• Act as SME for Stability within GQSS (e.g., perform statistical trend analysis for previous interval disagreements and risk assessments; review Topic 5.3 GDL revisions; revise SOPs as required; serve on audit and inspection teams as required; support stability related lab investigations and shipping excursions) 
• Act as SME and oversight of data entry into GLIMS  
• Participate in site and off-site project meetings 

Minimum Education & Experience: 

• Bachelor’s degree in a science field with a five (5) years of stability study management testing in pharmaceutical industry experience.  

Required Experience and Skills: 

• Ability to …