Title: Data Auditor AR&D
Location: Winchester KY 40391
Duration: 6 months
Schedule: M-F 8a to 5p onsite
Responsibilities: Read and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal client methods, customer/supplier methods and other technical documents. Perform technical review and approval of all data including notebooks/certificate of analysis, stability summaries for compliance with approved test methods, specification, and applicable internal SOPs for routine release testing of raw materials, in-process samples, finished products and stability samples for development batches, GMP/clinical batches and registration activities required for the regulatory submissions. Perform technical review and approval of data, protocols and reports related to method qualifications (transfers/verifications/validations) including other protocol-based studies (photostability, comparative dissolution studies, dose dump studies etc.) performed in AR&D required for regulatory submissions. Author / review SOP's that fall within defined area of subject matter expertise. Review other technical documents not limited to specification, test methods, Certificate of analysis/Report of analysis, protocols/reports, and other technical documents as needed. Participate in customer/internal/regulatory agency audits as necessary. Assist in training analytical scientists. Perform analytical testing as per business needs. Assist in laboratory investigations. Draft or review CAPAs and audit responses as needed. Requirements: PhD degree: 3+ years of pharmaceutical industry experience and a minimum of 2 years of analytical testing/research experience using HPLC/GC/UV, M.S. degree 4+ years of pharmaceutical industry experience and a minimum of 3 years of analytical testing/research experience using HPLC/GC/UV BS degree: 5+ years of pharmaceutical industry experience and a minimum of 3 years of analytical testing/research experience using HPLC/GC/UV, Proficient understanding with analytical chemistry calculations such as concentrations (Area%, w/w, ppm, µg/mL, etc.), molarity, Beer's Law, reference standard purity on as is, anhydrous, or dry basis etc. Ability to coordinate and prioritize to support manufacturing and quality agreements. Proficient using Empower software
