Experience working with external partners
Review of routine QC test data for product release, including identification and resolution of deviations, lab investigations
Review and analysis of stability data and retest dates, including identification and resolution
Analytical method lifecycle and supporting activities; development fit for purpose, qualification and validation, change management, transfer, and analytical performance monitoring/trending with emphasis on oversight and review
Product quality evaluation and trending, including setting and justification of product specifications for release and stability
Raw material control and testing requirements
Experience representing QC with external partners
Expertise with Quality systems including change control, deviation/CAPA, risk assessment, SOP authoring, review and approval
Depth of knowledge of industry guidelines and requirements for product quality and control
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The base salary range for this position is listed below. Your Amazon package will include sign-on payments and restricted stock units (RSUs). Final compensation will be determined based on factors including experience, qualifications, and location. Amazon also offers comprehensive benefits including health insurance (medical, dental, vision, prescription, Basic Life & AD&D insurance and option for Supplemental life plans, EAP, Mental Health Support, Medical Advice Line, Flexible Spending Accounts, Adoption and Surrogacy Reimbursement coverage), 401(k) matching, paid time off, and parental leave. Learn more about our benefits at https://amazon.jobs/en/benefits.
USA, WA, Seattle - 159,200.00 - 215,300.00 USD annually