Pathogenia Lab
Website:
pathogenia.com
Job details:
Role Description We are seeking a detail-oriented and scientifically driven GMP Laboratory Analytical Data Reviewer to join our Quality team. The successful candidate will be responsible for performing thorough technical and compliance reviews of laboratory analytical data and supporting documentation to ensure accuracy, completeness, traceability, data integrity, and compliance with GMP requirements.
Key Responsibilities
Perform detailed review of analytical laboratory data packages, including raw data, chromatograms, calculations, worksheets, laboratory notebooks, and electronic records.
Review data generated from analytical techniques such as HPLC/UPLC, GC, UV-Vis, FTIR, dissolution, Karl Fischer, and other laboratory instrumentation, as applicable.
Verify calculations, system suitability, sample and standard preparation, instrument status, sequence information, integration, and specification compliance.
Ensure laboratory data comply with GMP/cGMP, SOPs, Good Documentation Practices (GDP), and ALCOA+ data integrity principles.
Review electronic data and audit trails using applicable laboratory software and systems such as Empower, LIMS, or equivalent platforms.
Identify and document discrepancies, atypical results, OOS/OOT results, documentation deficiencies, and potential data integrity concerns.
Support OOS/OOT investigations, deviations, CAPAs, change controls, and laboratory investigations.
Review stability, release, raw material, in-process, and finished-product analytical data, as applicable.
Evaluate data trends and identify recurring laboratory or analytical issues.
Ensure analytical records are complete, scientifically sound, traceable, and inspection-ready.
Collaborate with QC Analysts and QA to resolve review comments and compliance issues.
Qualifications
Bachelor's degree or college diploma in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or a related scientific discipline.
2–5+ years of experience in a pharmaceutical, biotechnology, contract laboratory, or other GMP-regulated laboratory environment.
Strong experience with analytical data review and laboratory documentation.
Hands-on knowledge of analytical techniques such as HPLC/UPLC, GC, UV-Vis, FTIR, dissolution, or related instrumentation.
Strong understanding of GMP/cGMP, GLP, GDP, data integrity, and ALCOA+ principles.
Experience with chromatography/data systems such as Empower, LIMS, or equivalent is highly desirable.
Experience with OOS/OOT investigations, deviations, CAPA, stability testing, and/or method validation is an asset.
Strong analytical thinking, attention to detail, organization, and problem-solving skills.
Excellent written and verbal communication skills.
Ability to work independently while collaborating effectively with QC, QA, and other cross-functional teams.
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