Data Reviewer, Quality Control

Responsibilities

• Perform independent technical review of internal data and external laboratory data.
• 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: Working knowledge of USP, ISO, FDA and ICH guidelines, familiarity with 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.