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Quality Assurance Scientist

Company: TSR Consulting Services, Inc.
Location: New Brunswick
Posted on: January 16, 2020

Job Description:

Title: Quality Assurance ScientistLocation: New Brunswick, NJW2 ONLYJob Description: Review policies, SOPs and other procedural documents for the client portfolio of clinical and commercial pharmaceutical and biopharmaceutical products against regulatory guidances and other external or internal cGMP standards for laboratory controls (e.g., 21 CFR 211, Eudralex Volume 4, Pharmaceutical Administration and Regulations in Japan, ICH guidelines) to develop global Analytical Quality Standards Review analytical documentation, including, but not limited to the following, to aid in the development of Analytical Quality Standards Certificates of Analysis for reference materials and critical reagents Reference Standard and Critical Reagent qualification protocols and reports Standard Operating Procedures and other guidance documents Analytical methods and associated change controls Analytical method validation protocols and reports for in-process and release/stability testing Method technical transfer protocols and reports Perform the QA review/approval of technical documentation, including, but not limited to: Analytical method validation protocols and reports for in-process and release/stability testing Analytical method procedures and associated change controls Method technical transfer protocols and reports Reference materials and critical reagents Standard Operating Procedures and other guidance documents Qualifications BS/BA in a life science field Minimum of 8 years of experience in a Quality Assurance organization responsible for the review of documents pertaining to release and stability analytical test methods for small molecules drug substances and drug products Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials Excellent communication skills Knowledge of compendial compliance evaluation and analytical methodology for biologics drug substances and drug products is a plusIf Interested, please send your updated resume to dpatel@tsrconsulting.com and reach out to Devan Patel 732-321-9000 ext. 4247 ASAP, thank - provided by Dice

Keywords: TSR Consulting Services, Inc., New Brunswick , Quality Assurance Scientist, Other , New Brunswick, New Jersey

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