Job Description

Department: Field - FG Location: Juncos, 077
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Specialist QA
  • 2100 to 0530 AST (M – F)

    • SUMMARY

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



    FUNCTIONS

    - 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.



    EDUCATION

    -Bachelors + 4 years of directly related experience OR



    COMPETENCIES/SKILLS

    - Project management skills.

    - Strong organizational skills, including ability to follow assignments through to completion.

    - Initiate and lead cross functional teams.

    - Enhanced skills in leading, influencing and negotiating.

    - Strong knowledge in area of expertise.

    - Collaborate and coordinate with higher level outside resources.

    - Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.

    - Demonstrate ability to interact with regulatory agencies.

    - Strong word processing, presentation, database and spreadsheet application skills.

    - Strong communication (both written and oral), facilitation and presentation skills.

    - Strong skill in working independently and to effectively interact with various levels.

    - Advanced data trending and evaluation.

    - Ability to evaluate compliance issues.

    PREFERRED:

  • Supply Chain
  • Incoming sampling and inspection
  • Quality audit of warehouse floor operations
  • Proficient in Smartsheet, Generative AI, Power BI, SAP
  • Initiating and approving Quality deviations (nonconformances)
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