Browse New and Exciting Opportunities
QC Stability Specialist
- Execute day to day operations of the stability activities through sample receipts, aliquoting, stability sample set-down, data compilation.
- Responsible for authoring of stability protocols to establishing our Internal stability management capabilities.
- Provide oversight to CMOs/CTLs to ensure that studies conducted externally are executed compliantly and studies are set down on time
- Responsible for entering stability data into slide decks, and spreadsheets
- Responsible for the resolution and on-time completion of stability-related deviations, CAPAs, and Change Controls by providing technical expertise, as appropriate.
- Responsible for managing the shipment of stability materials to different sites as needed
- Responsible for generating, updating, and stability-related SOPs, as appropriate.
- Responsible for ensuring that the stability-related forms / documents adhere to GXP requirements and internal SOPs.
- Other duties as assigned.
Requirements / Qualifications:
- 2-5 years’ experience in a GxP environment
- Bachelors in a Life Science
- Scientific background in Stability or Analytics for Biologics
- Experience with LIMS preferred