Senior QC Stability Scientist

My client is expanding and seeks a Stability Scientist to take on the following tasks:

• Oversee the operations of the stability program through data analysis and approval of protocols and reports.
• Manage CMOs and ensure that studies conducted externally are executed compliantly and on time.
• Ensure completion of stability-related deviations, CAPAs, and Change Controls by providing technical oversight.
• Generate, update, and retire stability-related SOPs.
• Ensure that the stability-related forms and documents adhere to GXP requirements and internal SOPs.
• Represent QC Stability on cross functional teams.

• BS degree and 8+ years of relevant experience in a GxP environment with at least 3 years of Stability experience in a GMP regulated environment.
• Experience with analytical methods and stability of biologics, as well as writing SOPs, investigations, stability protocols and reports.
• Experience working with LIMS and statistical software and interfacing with CMOs/CTLs.
• Exceptional organizational and time management skills coupled with strong communication skills.