Sr. Specialist QA 35713

PR·Juncossenior

OtherQa Specialist

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Quick Summary

Key Responsibilities

Quality Assurance & ComplianceThe role requires strong ownership of site-level quality activities, including quality systems, compliance assessments, investigations, incident management,

Requirements Summary

Facilities and Utilities Commissioning and Qualification, Computer System Validation, Equipment validation, Risk Assessments & Management Softwares: KNEAT, CDOCS, SCADA, TRACKWISE,

Technical Tools

OtherQa Specialist

In support of site's Quality Assurance program acts as the technical specialist. Review and approve product MPs.

Requirements

~1 min read

Facilities and Utilities Commissioning and Qualification, Computer System Validation, Equipment validation, Risk Assessments & Management
Softwares: KNEAT, CDOCS, SCADA, TRACKWISE, MAXIMO
Good Documentation Practices, Data Integrity, Change Controls, Standard Operation Procedure
Experience with Syringe/Vials Inspection Process
Documents revision and approval
Strong knowledge in Decision Making Techniques

Responsibilities

~1 min read

→Doctorate + 2 years of directly related experience or Masters + 4 years of directly related experience or Bachelors + 6 years of directly related experience or Associates + 10 years of directly related experience or High school/GED + 12 years of directly related experience