Specialist QA

hace 2 horas

Juncos, Puerto Rico Inteldot A tiempo completo

Inteldot has over 14 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Responsibilities:

  • Review and approve product Master Plans (MPs).
  • Approve process validation protocols and reports for manufacturing processes.
  • Participate in Quality on Incident Triage Team.
  • Approve Environmental Characterization reports.
  • Release sanitary utility systems.
  • Approve planned incidents.
  • Represent QA in the New Product Introduction (NPI) team.
  • Lead investigations and site audits.
  • Own and maintain site quality program procedures.
  • Serve as QA Manager designee on local Change Control Review Board (CCRB).
  • Review and assess risk evaluations.
  • Support automation activities, facilities, and environmental programs.
  • Review and approve Work Orders and EMS/BMS alarms.
  • Approve non-conformance (NC) investigations and CAPA records.
  • Approve change controls

Job Requirements:

  • New Product Introduction
  • Change Control
  • FATs
  • Validation, and PPQs

Education & Experience:

  • 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.

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