Talent.com
Esta oferta de trabajo no está disponible en tu país.
Specialist QA 34383

Specialist QA 34383

InteldotJuncos, Puerto Rico
Hace 3 días
Descripción del trabajo

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

Administrative shift

Job Description :

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

Requirements :

  • Experienced quality assurance specialist.
  • Commissioning and Qualification of Equipment / Systems / Facilities
  • Auditing Equipment / Facilities / Utilities of Qualification Protocols and execution
  • Revision and approvals of technical documents like URS, Design, Report of technical data.
  • Deep knowledge of quality assurance terminology, methods, and tools
  • Knowledge on Veeva, CDOCS applications.

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 and planned incidents
  • Release of sanitary utility systems.
  • Represent QA on NPI team.
  • Lead investigations and site audits
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.
  • Review Risk Assessments.
  • Support Automation activities and facilities and environmental programs.
  • Review and approve work orders and EMS / BMS alarms.
  • Approve NC investigations, change control and CAPA records
  • Provide lot disposition and authorize lots for shipment.
  • Education

  • 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.
  • Science or Engineering bachelor
  • Pharmaceutical environment experience
  • Spoken languages : Spanish and English
  • Crear una alerta de empleo para esta búsqueda

    Specialist Qa • Juncos, Puerto Rico