Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.

Description:

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

Responsibilities:

  • 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.

Competencies / Skills:

  • Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
  • Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
  • Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning, facility, utility, and equipment qualifications.

Education:

  • Master's degree and 3 years of directly related experience o Bachelor's degree and 5 years of directly related experience years of directly related experience.

Compensation and Benefits:

  • Employment (W2) and Professional Services Contract (480) available.
  • Administrative, as per business need.
  • Competitive Pay Rate