Data Reviewer, Analytical Development

Responsibilities

• Evaluate data for accuracy, completeness, and compliance with GMP and specifications
• Independently evaluate, 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 reports, IPC data, cleaning samples, and logbooks for traceability and compliance
• Communicate and 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 and support implementation of 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 and opportunities for trend analysis, system suitability trending.

Requirements

• Bachelor’s degree in chemistry or any STEM degree and 5+ years GMP experience, or a Master of Science (STEM degree) with minimum 3 years of experience in a cGMP laboratory (pharmaceutical CMO/CRO)
• Experience with analytical data review and documentation practices
• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, LC-MS, NMR, FTIR, Appearance, pH, KF, UV spectrometry and microbiology testing
• Working knowledge of GMP/GDP and laboratory systems
• Preferred: Familiarity with USP, ISO, FDA and ICH guidelines, working knowledge of laboratory information systems, LIMS, strong verbal and written communication skills, ability to work with diverse professionals in a matrix environment, solid organizational skills, ability to adapt to changing priorities and deadlines