QA, Data Reviewer (Chemist)

Job Title:

QA, Data Reviewer (Chemist) Job Summary This position is dedicated to the review, verification, and assessment of analytical data generated within the Quality Control laboratory. The role ensures that all laboratory documentation meets cGMP, regulatory, and internal quality standards. Responsibilities do not include performing laboratory testing, operating instruments, or releasing materials or products. 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. 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. Assess data for compliance with approved analytical methods, compendial requirements, SOPs, and cGMP expectations, ensuring consistency across diverse analytical techniques. 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. Identify discrepancies, atypical trends, integration anomalies, missing data, or potential data integrity concerns and escalate findings promptly. Confirm that all raw data, worksheets, logbooks, electronic records, and metadata comply with ALCOA+ principles and meet internal documentation standards. Review LIMS entries for accuracy, completeness, and proper linkage to supporting raw data and metadata. 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. Education & Experience Minimal acceptable level of education, work experience and certifications required for the job Bachelor of Science Degree in chemistry, chemical engineering or related field with 4+ years' relevant analytical laboratory experience OR Master's Degree in above disciplines with 2+ years' relevant analytical lab experience Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. 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 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. Thorough knowledge of applicable safety and standards guidelines, such as SOP, c

GMP, GLP, DEA

regulations and/or MSDS Has demonstrated competence in conducting chemical analyses Strong knowledge of wet chemistry techniques Competency in Microsoft Office Suite Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. Ability to critically review and analyze data, interpret information, and draw conclusions from relevant or missing information, reporting to management Ability to display and analyze data in a logical manner Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information Ability to display and analyze data in a logical manner Strong verbal and written communication skills as well as good computer skills Strong attention to details and accurate record keeping Establish and maintain cooperative working relationships with others Solid organizational skills Ability to coach less senior staff and develop laboratory skills and ability Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. 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. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals Must occasionally lift and/or move up to 15-25 lbs. Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods