FSP - QC Specialist – Biologics Stability
Core
Provide operational and technical support for GMP-compliant biologics stability programs, including data analysis, reporting, and protocol management.
Role type
QC Biologics Stability Specialist
Builds
Stability summary reports, regulatory submissions, shelf-life extensions, and stability trackers
Domain
Biologics / Life Sciences / Quality Control
Required skills
GMP principles, biologics stability programs, data analysis (JMP), LIMS systems, regulatory standards, protocol creation, data trending
Preferred skills
Cross-functional collaboration, problem-solving, organizational skills
Technologies
JMP, LIMS, Smartsheets
Responsibilities
Perform data analysis using JMP for quarterly trending and regulatory submissions; Generate Stability Summary Reports (SSRs) from LIMS; Verify data for non-regulatory reports and support investigations; Maintain molecule-specific stability trackers and shipping forecasts; Draft temperature excursion memos and initiate stability studies; Collaborate with stability leads to ensure compliant execution
Seniority
Mid-Senior, hands-on IC