Quality Assurance Specialist

hace 4 semanas


Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo
Job Title: Quality Assurance Specialist

Validation & Engineering Group, Inc. is seeking a talented Quality Assurance Specialist to join our team.

Job Summary

We are looking for a Quality Assurance Specialist with experience in manufacturing process audit and batch record review. The ideal candidate will have knowledge of DAI process, PASx/MES application, MAXIMO, SAP, and LIMS.

Key Responsibilities
  • Review and approve product manufacturing processes
  • Approve process validation protocols and reports for manufacturing processes
  • Request Quality on incident triage team
  • Approve Environmental Characterization reports
  • Release of sanitary utility systems
  • Approve planned incidents
  • Represent QA on NPI team
  • Lead investigations
  • Lead site audits
  • Own site quality program procedures
  • Designee for QA manager on local CCRB
  • Review Risk Assessments
  • Support Automation activities
  • Support facilities and environmental programs
  • Review and approve Work Orders
  • Review and approve EMS/BMS alarms
  • Approve NC investigations and CAPA records
  • Approve change controls
  • Provide lot disposition and authorize lots for shipment
Requirements

We are looking for a candidate with a Doctorate degree, or Master's degree and 3 years, or Bachelor's degree and 5 years of directly related experience.



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