Quality Control Sr Analyst

Position Summary

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.

Key Accountabilities

• Laboratory Investigation Ownership: Lead, author, coordinate, and complete laboratory investigations involving OOS, OOT, atypical, invalid, questionable, or unexpected results and laboratory-related deviations.
• Phase I Laboratory Assessment: Conduct and document prompt laboratory assessments that evaluate analyst execution, calculations, sample and standard preparation, reagents and solutions, method requirements, instrument condition, system suitability, chromatograms, integration, processing parameters, environmental conditions, maintenance, calibration, and other relevant laboratory controls.
• Full-Scale Investigation Support: Coordinate with QA, Manufacturing, Technical Services, Regulatory Affairs, and other functions to support an expanded investigation of manufacturing, sampling, materials, methods, and prior history.
• OOS/OOT Governance: Maintain active oversight of assigned OOS/OOT records from initiation through closure.
• Root Cause Analysis: Apply structured root-cause tools and scientific critical thinking to distinguish assignable cause, contributing factors, systemic causes, method variability, instrument or system issues, sampling issues, and potential manufacturing causes.
• CAPA Development and Effectiveness: Develop risk-based corrective and preventive actions that address confirmed root and contributing causes.
• Analytical Data Review: Perform independent, comprehensive review of raw data and reported results for routine, release, stability, validation, transfer, and investigation testing.
• Electronic Data and Metadata Review: Review complete electronic records, relevant metadata, sequence information, processing histories, audit trails, deleted or aborted injections, reinjections, reprocessing, reintegration, manual entries, date and time information, user actions, and unexplained or unreported data.
• Data Integrity Compliance: Apply ALCOA+ principles to paper, electronic, and hybrid laboratory records.
• Audit Trail Review: Execute and document risk-based audit-trail reviews for applicable laboratory systems.
• Laboratory Systems and Controls: Partner with QC management, QA, IT, validation, metrology, and system owners to evaluate laboratory computerized systems, user access, segregation of duties, time synchronization, method and processing controls, data paths, interfaces, backup and archival arrangements, and system limitations.
• Method and Instrument Technical Assessment: Use advanced knowledge of HPLC and other laboratory technologies to assess method execution and performance.
• Trend Analysis and Metrics: Trend OOS/OOT events, invalidations, repeat testing, reintegration, analyst and instrument factors, recurring root causes, CAPA effectiveness, aging, and investigation cycle time.
• SOPs, Tools, and Continuous Improvement: Author or revise procedures, investigation templates, checklists, decision trees, data-review tools, and training materials.
• Training and Technical Mentoring: Train and mentor analysts, reviewers, and investigators on OOS/OOT requirements, investigation documentation, hypothesis testing, root-cause analysis, CAPA quality, Good Documentation Practices, electronic data review, audit trails, and data-integrity expectations.
• Inspection and Audit Readiness: Maintain investigation and data-review records in an inspection-ready state.
• Cross-Functional Communication: Provide clear, factual, and timely updates to the Associate Director QC, QA, project teams, and other stakeholders.
• Laboratory Testing Support: As business needs require and within current qualification, perform or support analytical testing, standards and sample preparation, LIMS documentation, peer review, protocol and report preparation, and laboratory troubleshooting.
• Workload Ownership: Independently prioritize multiple investigations, reviews, CAPAs, and improvement activities.

Education / Experience

• Education: Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline is required. An advanced scientific degree is preferred.
• Laboratory Experience: Minimum five (5) years of pharmaceutical Quality Control laboratory experience in a GMP-regulated environment, including independent analytical testing and data review.
• Investigation Experience: Demonstrated experience authoring or leading laboratory investigations, including OOS/OOT assessments, hypothesis testing, root-cause analysis, product-impact evaluation, CAPA development, and effectiveness verification.
• Analytical Expertise: 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.
• Data Integrity: 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.
• Regulatory Knowledge: 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.
• Systems: Experience with laboratory systems such as LIMS, chromatography data systems, electronic QMS, SAP, instrument software, or comparable platforms is preferred.
• CDMO Experience: Experience supporting multiple products, customers, methods, and concurrent priorities in a CDMO/CMO environment is preferred.

Job Competencies

• Advanced scientific investigation, critical-thinking, root-cause analysis, and technical-writing capability.
• High attention to detail and ability to critically review complex paper and electronic analytical records.
• Sound, independent Quality judgment with willingness to question unsupported conclusions and escalate risk.
• Ability to separate facts, observations, hypotheses, and conclusions and communicate each clearly.
• Strong knowledge of chromatography, laboratory controls, OOS/OOT principles, CAPA systems, and data-integrity expectations.
• Ability to influence and coordinate analysts, laboratory leadership, QA, IT, validation, and cross-functional SMEs without direct authority.
• Strong organization, prioritization, and follow-through across multiple time-sensitive investigations and reviews.
• Clear written, verbal, presentation, and inspection-interaction skills.
• Commitment to transparent reporting, patient and product protection, and an open Quality culture.