FSP - QC Reviewer
Core
Review raw data, verify numerical data for regulatory filings, and evaluate laboratory data for compliance with analytical methods and SOPs within a pharmaceutical/biopharmaceutical setting.
Role type
QC Reviewer (Analytical Services)
Builds
Regulatory filings, QC metrics, clinical and commercial stability protocols
Domain
Life Sciences / Clinical Research / Analytical Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SOP knowledge, GLP/GMP regulations, chromatography expertise, laboratory procedures, data verification, protocol authoring, staff training
Preferred skills
None stated
Technologies
None stated
Responsibilities
Review raw data, perform numerical data verification for regulatory filings, transcribe SOPs, consolidate data for QC metrics, author clinical and commercial stability protocols, evaluate laboratory data for compliance, review sample results for completeness, communicate with laboratory staff to address documentation quality, prepare QC statements noting deficiencies, train new QC Reviewers and laboratory staff, conduct SOP review and writing
Seniority
Mid-level, hands-on IC