Quality Control Data Review Specialist

We are seeking a detail-oriented Quality Control Data Review Specialist to support our analytical chemistry and quality operations. In this role, you will collaborate directly with chemists and microbiologists to perform independent, rigorous reviews of both routine and complex laboratory data-including chromatographic results (HPLC/GC), spectroscopy (FTIR), and physical measurements. You will play a critical role in maintaining GxP compliance by utilizing electronic laboratory systems to evaluate data accuracy, verify test results, and support Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations., Perform routine quality control data reviews for foundational laboratory tests, including reagent logs, pH measurements, and visual inspections. Execute complex analytical data reviews for chromatographic systems (HPLC, GC), titrators, density meters, and FTIR spectroscopy. Partner with chemists and microbiologists to investigate, document, and help resolve Out-of-Specification (OOS) and Out-of-Trend (OOT) analytical results. Utilize specialized electronic programs and laboratory software to assess, verify, and document quality control and quality assurance processes. Ensure all reviewed analytical documentation strictly complies with current Good Manufacturing Practices (cGMP) and internal data integrity guidelines. Support ongoing quality compliance activities, laboratory audits, and operational workflows as needed.

Experience: Minimum of 2+ years of hands-on experience working within a regulated GxP laboratory environment. Technical Skills: Direct, practical experience performing analytical chemistry data review (e.g., HPLC, GC, FTIR, physical chemistry assays). Regulatory Knowledge: Solid understanding of cGMP regulations, cGxP compliance, and data integrity principles. Software & Communication: Proficiency in Microsoft Office applications with strong written and oral English communication skills to document technical findings clearly. Preferred Qualifications Practical experience navigating enterprise Laboratory Information Management Systems (LIMS). Hands-on experience reviewing chromatography and spectroscopy data within software systems such as Waters Empower, Mettler Toledo LabX, or Thermo Scientific OMNIC.