Specialist ELISA - QC
Core
Subject matter expert for ELISA methods supporting QC analysts, investigating deviations, and leading continuous improvement initiatives within a GMP-compliant environment.
Role type
Specialist ELISA - QC (Quality Control)
Builds
ELISA potency testing results, deviation reports, and corrective/preventive action plans
Domain
Life Sciences / Pharmaceutical Quality Control
Deliverable
dashboards & analysis
Required skills
ELISA technique expertise, GMP knowledge, data analysis, root cause investigation, change control management, SOP development
Preferred skills
Lean/Six Sigma tools (Kaizen, 8-step root cause), problem-solving techniques
Technologies
ELISA, GMP systems, OOS management tools
Responsibilities
Support QC analysts with ELISA method questions, identify and analyze OOS deviations, implement CAPA and root cause investigations, lead change controls for ELISA methods, assess QC test results, serve as QC department contact for audits and training
Seniority
Mid-level Specialist (3-5 years experience)