The QC Analytical Chemistry Data reviewer will review analytical data, technical reports, protocols, final reports, stability reports and other forms of documentation as required to ensure they are correct, complete and compliant. Communicate review observations to personnel responsible for the results to ensure all appropriate review observations are properly addressed and documented.
Performs review of analytical data and calculations associated with, but not limited to Raw material, Reference standard, API, and Finished Product testing, analytical method transfer, optimization and development/validation design and analytical methods development/validation of drug substances, drug product and residual testing, using guidelines from USP and ICH and in accordance with laboratory SOPs. Reviews technical reports, protocols, final reports, stability reports and other forms of documentation as required. This will include the preparation and review of all data supporting regulatory filings, such as CMCs and NDAs; with the preparation, review, auditing and control of Methods Development documents including, but not limited to protocols, reports, laboratory notebooks, general practices, batch cards, test request, material specifications, certificates of analysis & compliance, and standard operating procedures; and to issue progress reports regarding the results and status of the review and audits of these documents.
A Bachelor’s degree in Chemistry with a minimum of 3-5 years of laboratory experience, preferably in the pharmaceutical industry.
Must possess a clear understanding of cGMP requirements as they apply to pharmaceutical analytical data for test samples, and demonstrate good attention to detail. Possess an understanding of cGMPs relating to documentation requirements for the final release of analytical test data. Knowledge of the operation of analytical instrumentation and software. Proficient in chromatography software for analysis and review purposes, understanding of analytical method development/validation. Must have strong scientific writing and reviewing experience. Requires a minimum of 3 years of experience in a Pharmaceutical GMP environment or testing laboratory including experience with HPLC, GC, Karl Fisher, UV/VIS, FTIR, LC/MS, ICP/MS, NMR, lab software such as Empower 3, OpenLab, or equivalent. Clear understanding of requirements for testing of pharmaceuticals using USP, EP, BP and JP methods of analysis, preparing cGMP and other laboratory documents, cGMP, FDA, ICH, EU regulations, and MSDSs. Excellent organizational skills, effective communication both verbally and written, proficient in Microsoft Office Word, Excel, Access, and PowerPoint.