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ZL01-082724 Specialist QA [Non-Standard Shift]

ZL01-082724 Specialist QA [Non-Standard Shift]

Validation & Engineering Group, IncJuncos, 077
Hace más de 30 días
Descripción del trabajo

Department : Field - FG Location : Juncos, 077

START YOUR APPLICATION

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :

  • Specialist QA
  • Shift : Mon / Tue then Fri / Sat / Sun on alternate weeks from 5 : 00 AM to 5 : 30 PM or from 5 : 00 PM to 5 : 30 AM.

Summary

Quality Professional with Manufacturing Process Audit and Batch Record Review experience. In addition, some knowledge or to be familiar with DAI process, PASx / MES application, MAXIMO, SAP and LIMS.

Functions

  • Review and approve product MPs.
  • 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.
  • EDUCATION / LICENSES

  • Doctorate degree, or Master's degree and 3 years, or Bachelor's degree and 5 years of directly related experience.
  • START YOUR APPLICATION

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