QA Specialist

QA SpecialistPerform the QA review/approval of analytical documentation: Analytical method validation protocols and reports for in-process and release/stability testing Analytical method procedures and associated change controls Method technical transfer protocols and reports Reference Standard and Critical Reagent qualification protocols and reports Certificates of Analysis for reference materials and critical reagents Standard Operating Procedures and other guidance documents Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications Collaborate with manufacturing support functions to develop the methods and acceptance criteria for the development of raw material specifications in preparation for Process Performance Qualification activities Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials Experience with the review and approval of method validation protocols and reports Experience collaborating with technical teams to develop validation strategies that are compliant to regulatory guidance and BMS policies Experience collaborating with technical subject matter experts to resolve validation protocol or report compliance gaps and indicate if technical gaps are present with the overall validation strategy Experience collaborating with technical subject matter experts to resolve protocol deviations and investigations