Sr. Quality Specialist, Laboratory Investigations & Data Integrity

The Senior Quality Specialist, Laboratory Investigations & Data Integrity is an experienced Quality Control individual contributor responsible for leading and completing laboratory investigations, OOS/OOT assessments, CAPA development, and comprehensive review of analytical data in a cGMP pharmaceutical laboratory. Reporting to the Associate Director, Quality Control, the role applies scientific and regulatory judgment to determine root cause, assess product and data impact, document defensible conclusions, and drive timely actions to closure.

Responsibilities

Lead, author, coordinate, and complete laboratory investigations involving OOS, OOT, atypical, invalid, questionable, or unexpected results and laboratory-related deviations; Conduct and document Phase I laboratory assessments; Coordinate expanded investigations with QA, Manufacturing, Technical Services, and Regulatory Affairs; Maintain oversight of OOS/OOT records from initiation through closure; Apply structured root-cause analysis; Develop risk-based CAPAs and track effectiveness checks; Perform independent comprehensive analytical data review and electronic data and metadata review; Apply ALCOA+ principles and execute risk-based audit-trail reviews; Partner on laboratory computerized system controls; Assess HPLC and other laboratory method and instrument performance; Trend OOS/OOT events and report adverse trends to QC and Quality leadership; Author or revise SOPs, templates, and training materials; Train and mentor analysts and reviewers on OOS/OOT, documentation, and data integrity; Maintain investigation and data-review records in an inspection-ready state; Support laboratory testing as business needs require

Requirements

Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline; Minimum five (5) years of pharmaceutical Quality Control laboratory experience in a GMP-regulated environment, including independent analytical testing and data review; Demonstrated experience authoring or leading laboratory investigations, including OOS/OOT assessments, hypothesis testing, root-cause analysis, product-impact evaluation, CAPA development, and effectiveness verification; Hands-on experience with HPLC and applicable techniques such as GC, dissolution, UV-Vis, FTIR, Karl Fischer, pH, particle-size analysis, XRD, wet chemistry, titration, viscosity, conductivity, or other compendial testing; Demonstrated ability to review electronic raw data, metadata, chromatographic processing, audit trails, LIMS records, and hybrid records in accordance with ALCOA+ and cGMP data-integrity expectations; Strong working knowledge of FDA OOS and data-integrity guidance, 21 CFR Parts 210 and 211, 21 CFR Part 11 as applicable, USP/EP requirements, Good Documentation Practices, and scientifically sound investigation principles

Nice to have

Advanced scientific degree; Experience with laboratory systems such as LIMS, chromatography data systems, electronic QMS, SAP, instrument software, or comparable platforms; Experience supporting multiple products, customers, methods, and concurrent priorities in a CDMO/CMO environment; Clear written, verbal, presentation, and inspection-interaction skills