Data Reviewer, Quality Control

Responsibilities: Perform independent technical review of internal and external laboratory data Evaluate data for accuracy, completeness, and compliance with GMP and specifications Investigate and document discrepancies, atypical results, and documentation inconsistencies to determine impact and ensure appropriate resolution Review routine release and stability data, method validation data and report, IPC data, cleaning samples, and logbooks for traceability and compliance Communicate/collaborate with laboratory staff and CDMOs to resolve data quality issues Support audit readiness activities and participate in inspections Maintain knowledge of laboratory systems and software for effective review Recommend improvements to data review processes, documentation practices, and workflow efficiency Provide guidance and onboarding support to junior reviewers on review practices, documentation standards, and GMP expectations Embrace digital tools for trend analysis and system suitability trending Perform additional duties as assigned Requirements: Bachelor’s degree in chemistry (or any STEM degree) and 5+ years GMP experience, or Master of Science (STEM) with 3+ years in a cGMP laboratory (pharmaceutical CMO/CRO) Experience with analytical data review and documentation practices Working knowledge of analytical methods (HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry) and microbiology testing Working knowledge of GMP/GDP and laboratory systems Candidates must have current, valid authorization to work in the country where this role is located. Preferred: Working knowledge of USP, ISO, FDA, and ICH guidelines Familiarity with LIMS Strong communication skills; solid organization and deadline management #J-18808-Ljbffr Scorpion Therapeutics