Senior Analytical Data Reviewer

We are seeking a Senior Analytical Data Reviewer to support the review, verification, and approval of analytical testing data for pharmaceutical products, raw materials, intermediates, reference standards, and stability samples. The ideal candidate will have strong knowledge of analytical chemistry, laboratory instrumentation, cGMP/GLP requirements, data integrity, and technical documentation. This role will work closely with laboratory personnel, Quality Assurance, management, external testing laboratories, and clients to ensure analytical data is accurate, complete, traceable, and compliant with applicable regulations and company procedures., * Perform technical review of raw analytical data generated from compendial testing, including USP/NF, EP, JP, or client-specific methodologies.

• Review analytical data for accuracy, completeness, integrity, compliance, and traceability.
• Evaluate data generated using GC, HPLC/UHPLC, ICP-MS, IR, DSC, UV-Vis, Karl Fischer, optical rotation, dissolution, and other analytical techniques.
• Trend and evaluate stability data to identify inconsistencies, unexpected results, or trends that require further investigation.
• Verify calculations associated with stability samples, reference standards, raw materials, intermediates, and other laboratory testing.
• Prepare, enter, format, and review stability summary tables for accuracy and compliance with current procedures and templates.
• Compile analytical data and prepare data summaries, reports, and trending information for management.
• Collaborate with laboratory personnel to ensure analytical data review is performed in accordance with cGMP and data integrity requirements.
• Perform electronic data reviews and electronic signatures in accordance with applicable procedures.
• Verify traceability and appropriate documentation for samples, standards, reagents, instruments, and other laboratory materials.
• Confirm that instrument calibration, usage logbooks, reagent and standard shelf life, and applicable GDP requirements are current and properly documented.
• Review analytical testing data received from external and contract laboratories in accordance with site procedures.
• Ensure analytical testing is performed in compliance with cGMP requirements, company SOPs, approved methods, and applicable specifications.
• Support QA activities, including OOS investigations, CAPAs, deviations, change controls, and related investigations.
• Review and approve analytical test methods, SOPs, forms, protocols, reports, and other technical documents as assigned.
• Support supervisors with OOS investigations and completion of CAPA-related activities.
• Participate in customer and cross-functional technical discussions regarding analytical testing issues and data.
• Coordinate analytical and stability testing performed by contract testing laboratories.
• Attend internal and external training related to analytical techniques, cGMP, data integrity, procedures, and regulatory requirements.
• Provide training and technical guidance to new hires and lower-level Data Reviewers.
• Maintain a high level of compliance with company policies, procedures, safety requirements, and applicable regulatory standards.

Core Competencies

• Analytical Data Review
• cGMP / GLP Compliance
• Data Integrity
• Stability Data Review & Trending
• HPLC / GC / ICP-MS
• Compendial Testing
• OOS / CAPA Support
• Technical Documentation
• Electronic Data Review
• Laboratory Compliance
• Quality Assurance
• Contract Laboratory Coordination
• Technical Problem Solving
• Cross-Functional Collaboration

• Bachelor’s degree in Chemistry or a related scientific discipline with a minimum of 5 years of relevant industry experience, OR
• Master’s degree in Chemistry or a related scientific discipline with a minimum of 3 years of relevant industry experience.
• Strong understanding of analytical chemistry principles and laboratory testing practices.
• Working knowledge of analytical instrumentation, including:
• Gas Chromatography (GC)
• High-Performance Liquid Chromatography (HPLC/UHPLC)
• ICP-MS
• Infrared Spectroscopy (IR)
• Differential Scanning Calorimetry (DSC)
• UV-Vis Spectroscopy
• Karl Fischer titration
• Optical Rotation
• Dissolution testing
• Knowledge of applicable compendial standards, including USP/NF, EP, JP, and internal/client analytical methods.
• Understanding of cGMP, GDP, data integrity, and laboratory compliance requirements.
• Strong attention to detail with the ability to identify discrepancies, calculation errors, missing documentation, and data integrity concerns.
• Strong technical writing, documentation, communication, and organizational skills.
• Ability to work collaboratively with laboratory, QA, QC, manufacturing, and cross-functional teams.

Preferred:

• Experience working in a cGMP or GLP pharmaceutical, biotechnology, or contract development and manufacturing environment.
• Experience with stability testing and stability data review.
• Experience with electronic laboratory systems and electronic data review/signature processes.
• Experience supporting OOS investigations, CAPAs, change controls, and other QA initiatives.