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.

Description:

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

Functions:

  • 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.

Skills:

    • 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.

    Education:

    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