Specialist QA

11 hours ago


Juncos PR, United States PRPDG Full time

SUMMARY

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.

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.

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.
  • NPI, Change Control, FATs, Validation, and PPQs

Job Type: Full-time

Pay: $ $40.00 per hour

Experience:

  • Validation: 5 years (Preferred)
  • PPQs: 5 years (Preferred)
  • New Product Introduction (NPI): 5 years (Preferred)
  • Change Control: 5 years (Preferred)
  • FATs: 5 years (Preferred)

Work Location: In person



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