Quality Control Specialist
Core
Review analytical test results and documentation for Release, In-Process, and Stability testing in Advanced Therapies to ensure compliance with quality standards and regulations.
Role type
Quality Control Specialist (Data Review)
Builds
Analytical test data packages for regulatory release
Domain
Biopharmaceuticals / Advanced Therapies / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data review, Analytical method qualification/verification/transfer/validation, cGMP/GDP/FDA/EMA/ICH compliance, ALCOA+ principles, Liquid chromatography, pH measurement, iCIEF, ELISA, SEC, CE-SDS, Deviation/investigation support
Preferred skills
GMP setting experience, Continuous improvement implementation, Strategic guidance on documentation practices
Technologies
Liquid chromatography, pH meters, iCIEF, ELISA, SEC, CE-SDS
Responsibilities
Conduct comprehensive data review for Release, In-Process, and Stability testing; Evaluate analytical test method documentation; Ensure data compliance with cGMP, GDP, FDA, EMA, and ICH Guidelines; Verify data meets ALCOA+ principles; Monitor testing compliance with laboratory procedures; Support QA events, deviations, and investigations; Provide strategic guidance to QC analysts on Good Documentation Practices
Seniority
Specialist, 2+ years experience
