Preferred candidates will have 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.

Bilingual English/Spanish communication skills are preferred.

Requirements

-Doctorate OR Masters + 2 years of directly related experience OR

-Bachelors + 4 years of directly related experience OR

-Associates + 8 years of directly related experience OR

-High school/GED + 10 years of directly related experience.

Habilidades requeridas

Good Manufacturing Practices (GMP)Change Control Management (review and approval)Deviation Investigation and ManagementCorrective and Preventive Action (CAPA) ManagementProtocol Development and ReviewQuality Report and Procedure Authoring and ApprovalPackaging and Inspection Operations SupportGood Documentation Practices (GDP)Electronic Quality Management Systems (eQMS)Cross-functional Collaboration with Manufacturing, Engineering, and Process DevelopmentBilingual Communication (English/Spanish)Regulatory Compliance Awareness (GxP/regulatory requirements)

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