Specialist QA 34735

Posted 5 Days Ago
Be an Early Applicant
Juncos
In-Office
Mid level
Information Technology
The Role
The Specialist QA will support the client's Quality Assurance program, including process validation, incident triage, audits, and managing quality documentation under minimal supervision.
Summary Generated by Built In

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

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

Administrative shift

Requirements:

  • Experience with NPI, Change Control, FATs, Validation, and PPQs
  • 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 and audits.
  • Review Risk Assessments.
  • Approve NC investigations and CAPA records.
  • Approve change controls.

EDUCATION

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. (Life Science and Engineering)

    Top Skills

    Capa
    Change Control
    Fats
    Npi
    Ppqs
    Quality Assurance
    Risk Assessments
    Validation
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    The Company
    HQ: San Juan
    19 Employees
    Year Founded: 2004

    What We Do

    Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
    We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004

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