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
Quality control metrics and compliance reports for clinical and commercial stability protocols.
Domain
Life Sciences / Pharmaceutical / Biopharmaceutical
Required skills
SOP knowledge, GLP/GMP regulations, chromatography, laboratory procedures, data verification, transcription, 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
