Position Overview
Responsibilities & Duties:
1.1 Compliance and Quality
Perform all activities in compliance with GxP requirements.Follow quality and safety requirements in accordance with organizational policies, procedures, and regulatory guidelines.Ensure technical outputs align with Global Training Curricula for instrument operation, material handling, and certifications related to Quality Operations, Manufacturing, and EHS.1.2 Analytical Development and Troubleshooting
Troubleshoot analytical issues related to methods and instrumentation.Develop and validate analytical methods using LC-MS, GCMS and ICP-MS for E&L work flow and Nitrosamine work flow support.Develop GTI impurity methods using LC-MS and GC-MS.Assess existing data packages, evaluate feasibility, and recommend remediation where needed.Has strong knowledge of USP, PQRI, and BPOG guidelines for SUS and MUS systems,...