Analytical Chemistry Data Auditor

3 weeks ago


Winchester, United States The Fountain Group Full time

Details:

  • 100% onsite in Winchester, KY
  • Pay for this position is 34.00 to 37.50 hourly depending on experience
  • This position is a 6 month contract with the possibility of extension or conversion to permanent.

Essential Skills and Experience:
  • Education or Equivalent: B.S in Chemistry, Pharmaceutical Sciences or Life Sciences (Preferred in Analytical Chemistry) plus relevant experience

Knowledge/Skills Requirements:
  • Understand analytical chemistry calculations.
  • 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 (preferred)
  • 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.
Description:
  • 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.

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.

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