We are seeking a Quality Assurance Specialist to perform critical QA oversight activities, ensuring compliance with regulatory requirements, internal quality standards, and site procedures. This role requires the ability to work with minimal supervision while collaborating cross-functionally with Manufacturing, Engineering, Facilities, Validation, and Operations teams

Requirements

Masters + 2 years of directly related experience; or Bachelors + 4 years of directly related experience
Change Control, Documentation Review, Validation, PPQ
Fully Bilingual (English & Spanish)

Competências necessárias

Change ControlDocumentation ReviewValidationPPQ (Process Performance Qualification)Regulatory ComplianceInternal Quality Standards ImplementationSite Procedures / SOP AdherenceCross-functional Collaboration (Manufacturing, Engineering, Facilities, Validation, Operations)Independent Work / Self-management (ability to work with minimal supervision)Bilingual Communication (English & Spanish)

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