Data Review Specialist, Quality Control

Key Responsibilities

• Review analytical raw data (HPLC/UPLC, GC, spectrophotometry, pH, dissolution, device function & performance testing) to ensure accuracy in calculations, instrument suitability, standards, sequences, and chromatographic integration.
• Review and support trending of stability data across applicable drug products, raw materials, and device-related attributes to identify emerging trends, atypical results, potential OOT signals, and data patterns requiring escalation.
• Assist with interpretation of stability data in support of timepoint completion, stability reports, annual product reviews, regulatory submissions, and product lifecycle monitoring.
• Collaborate with QC Stability, Raw Materials, QA, Manufacturing, Supply Chain, and Analytical Development to evaluate data trends and determine whether observed patterns require investigation, CAPA, procedural updates, or enhanced monitoring.
• Support trending and monitoring of raw material data, including supplier lot-to-lot variability, retest/expiry data, CoA verification trends, and recurring analytical or documentation issues.

Qualifications

• Bachelor’s degree in Chemistry, Microbiology, Biochemistry, Biology, or related scientific discipline.
• 5+ years in a QC laboratory, or data review role or a similar GMP-regulated environment, with a track record of strong performance, reliability, and increasing responsibility.
• Strong working knowledge of cGMP, GLP, and data integrity expectations (ALCOA+).
• Ability to independently review laboratory data, identify discrepancies, and collaborate effectively with peers and stakeholders to resolve issues in a timely manner.
• Experience reviewing analytical chemistry and microbiology data (bioburden, endotoxin, EM trending, sterility).
• Familiarity with chromatography software (e.g., Empower) and microbiology testing documentation.
• Proficiency with electronic data management systems, including JPM, LIMS, Smartsheets and Empower.
• Familiarity with statistical software, JMP preferred.
• Prior experience with method validation and stability study protocols is a plus.