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 in Puerto Rico.


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


  • Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations.
  • Actively engage in Continues Improvement initiatives, programs, and projects.
  • Certify that MES / EBR change control and new implementations complies with stablished procedures and specifications following current procedures.
  • Ensures that production records, MES /EBR testing validation process results are completed, accurate, and documented according to written procedures and cGMP regulations.
  • Vigilant ensuring that changes that could potentially impact product quality are assessed according to procedures.
  • Strong collaboration and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures.
  • Strategic advisor to senior management of quality, compliance, supply, and safety risks.
  • Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed.
  • Champion Continuous Improvement initiatives and projects.
  • Provides support to Digital MES automated teams and provide quality oversight judgement during discussions.


    • Expertise in Quality Systems such as Deviations, Non-conformities, CAPA, and Change Control.
    • Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background technical proficiency).
    • 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.
    • Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, Process Development and validation.
    • Validated experience as Quality Contact for sophisticated projects involving document simplification with experience in commissioning and qualifications.


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

    Compensation and Benefits:

    • Employment (W2) and Professional Services Contract (480) available.
    • Non-Standard Shift. Support during extended hours including weekends, as per business needs.
    • Competitive Pay Rate