Data Auditor R&D

Solve IT Strategies is looking for a Data Auditor R&D. This role is located at Winchester, KY 40391.

ONSITE .6 + MONTHS . SHIFT - MON-FRI 8AM - 5PM.

The Main Responsibilities of a person are:

Read and understand test methods from multiple compendia (i.e., USP/NF, EP, JP), internal

methods, customer/supplier methods and other technical documents.
• Perform technical review and approval of all data including notebooks/certificate of analysis, stability summaries etc. 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.

Education or Equivalent:
• Ph.D., M.S, or B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry).
• o Work Experience – 3+ years of pharmaceutical industry experience with a Ph.D. degree, and with at least 2 years of analytical testing/research experience using HPLC/GC/UV, etc.
• o Work Experience – 4+ years of pharmaceutical industry experience with a M.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.
• o Work Experience – 5+ years of pharmaceutical industry experience with a B.S degree, and with at least 3 years of analytical testing/research experience using HPLC/GC/UV, etc.

Knowledge/Skills Requirements:
• Understand 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 multi-task with high efficiency.
• Ability to coordinate and prioritize to support manufacturing and quality agreements.
• Ability to work well under pressure and maintain efficiency both on an individual and team basis.
• Ability to communicate effectively.
• Strong knowledge in Empower software.
• Advanced knowledge and demonstrated performance in regard to all lab safety process and procedures and the ability to work safely with chemicals of varying potency.