We are seeking a Specialist QA with GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired.

Requirements

Degree in a related field with applicable experience:
Doctorate, Master's + 2 years of experience, Bachelor's + 4 years of experience, Associate's + 8 years of experience, High School Diploma/GED + 10 years of experience.
Bilingual English and Spanish communication skills.
Experience in Quality Assurance within a GMP-regulated environment.
Experience reviewing and approving Change Controls, Deviations, CAPAs, Protocols, Reports, and SOPs.
Experience supporting packaging and inspection operations.

Habilidades requeridas

GMP Quality AssuranceChange Control review and approvalDeviation investigation and managementCAPA management and oversightProtocol review and approvalReport review and approvalSOP review and approvalSupport for packaging and inspection operationsGood Documentation Practices (GDP)Electronic quality management systems (eQMS)Cross-functional collaboration with Manufacturing, Engineering, and Process DevelopmentBilingual English-Spanish communication

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