Specialist, Quality Control Execution Support (2nd Shift)
Core
Support end-to-end analytical method lifecycle management including new method introduction, technical transfers, equipment qualification, investigations, and routine assay monitoring for pipeline and commercial biopharmaceutical products.
Role type
Specialist, Quality Control Execution Support (Analytical Sciences)
Builds
Analytical methods, validated procedures, and technical documentation for QC operations
Domain
Biopharmaceuticals / Analytical Chemistry
Required skills
Analytical method development, HPLC, ELISA, PCR, Microbiological analysis, GMP compliance, Change control management, Technical troubleshooting, Regulatory documentation, Data analysis
Preferred skills
Six Sigma tools, Coaching, Stakeholder management, Risk management
Technologies
HPLC, ELISA, PCR, Bioassays, Karl Fischer Titrations, cGE, Dissolution testing
Responsibilities
Support new method introduction and technical transfers; Perform SME assessment for equipment performance qualification; Conduct investigations and author technical documentation; Manage change controls for analytical methods and equipment; Provide routine assay monitoring and lifecycle management; Train end users and site personnel on lab systems and methods.
Seniority
Specialist, hands-on IC
