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.
Analytical R&D Auditors are responsible for performing technical review of raw material/in process/finished good data for release and stability along with other protocol-based studies that are executed in AR&D for regulatory submissions. In addition, the responsibilities include supporting lab investigations, customer/agency audits and performing analytical testing as per business needs.
II. Specific Tasks & Duties
• 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.
• 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.
III. Essential Skills and Experience:
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/Client, 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.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.