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

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

Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.