Chemist Data Reviewer

Job Summary: <ul><li>This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory.&nbsp;</li><li>The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards.&nbsp;</li><li>Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products.</li></ul> Responsiblities: <ul><li>Review complete analytical data packages generated from a wide range of QC laboratory instrumentation, including HPLC, UPLC, GC, UV?Vis, FT?IR, Dissolution, X?Ray Diffraction (XRD), pH meters, Karl Fischer, ICP-MS, and other compendial or platform - specific systems.</li><li>Verify calculations, chromatographic integrations, peak assignments, system suitability criteria, and instrument audit trails across software platforms such as Empower, ChemStation, LabSolutions, ICP?MS data systems, and dissolution software.</li><li>Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques.</li><li>Evaluate raw data outputs such as chromatograms, spectra (UV, IR), dissolution profiles, XRD patterns, elemental analysis reports, pH logs, and mass spectrometry data for accuracy and scientific soundness.</li><li>Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly.</li><li>Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards.</li><li>Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata.</li><li>Ensure instrument-specific parameters (e.g., wavelength accuracy for UV, calibration curves for ICP?MS, dissolution run conditions, GC column performance) are appropriately documented and meet acceptance criteria.</li></ul> Requirements: Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years’ relevant analytical laboratory experience OR</li><li>Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience</li></ul> Knowledge: <ul><li>Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports</li><li>Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.</li><li>Thorough knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS</li><li>Has demonstrated competence in conducting chemical analyses</li><li>Strong knowledge of wet chemistry techniques</li><li>Competency in Microsoft Office Suite</li></ul> Skills &amp; Abilities: <ul><li>Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management</li><li>Ability to display and analyze data in a logical manner</li><li>Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information</li><li>Ability to display and analyze data in a logical manner</li><li>Strong verbal and written communication skills as well as good computer skills</li><li>Strong attention to details and accurate record keeping</li><li>Establish and maintain cooperative working relationships with others</li><li>Solid organizational skills</li><li>Ability to coach less senior staff and develop laboratory skills and ability</li><li>Ability to take initiative, set priorities and follow through on assignments</li></ul> Physical Requirements: <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.&nbsp;</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods</li></ul>

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Chemist Data Reviewer

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Chemist Data Reviewer

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