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

• 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.

• Working knowledge of USP, ISO, FDA, and ICH guidelines
• Familiarity with LIMS
• Strong communication skills; solid organization and deadline management