Full job description Computech Corporation has over 25 years of experience providing contract, temporary, and direct-hire staffing services. We successfully work with public and private sector entities nationwide and offer staffing solutions for Information Technology (IT), Engineering, Medical, Professional, Finance, Administrative, Light industrial, Manufacturing, and other workforce needs.
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Phone Number: Job Title: Data Auditor AR&D Location: Winchester KY 40391 Duration: 6 + Months Schedule : Mon-Fri 8AM - 5PM. Pay Rate: $36/hr on W2 This position supports laboratory data auditing that includes reviewing the technical documents like protocols/reports/test methods, specifications, and the SOPs etc. related to AR&D with minimum supervision from the supervisor. Employees at this level can manage their time effectively while executing a broad range of high visibility tasks to provide scheduling and alignment for the AR&D Department in support of internal and external customers. This position requires strong knowledge of technical and analytical requirements of AR&D laboratory.
Duties 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. 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. Experience &Education: Ph.D., M.S, or B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry). 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. 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. H_HC Job Type: Contract
Pay: $33.00 - $36.00 per hour
Experience:
pharmaceutical industry: 4 years (Required) analytical testing/research: 4 years (Required) HPLC/GC/UV: 4 years (Required) Work Location: In person
