• Jt124 - Specialist QA

    Quality Consulting Group (Juncos, PR)


    QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

    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.

    + 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.

    Qualifications:

    + Bachelor's degree in engineering or life sciences.

    + Preferred Experience in Quality Assurance role.

    + 5 years of directly related experience

    + Proficiency in Quality Management Systems

    + Inspection Processes (automatic and manual)

    + Equipment knowledge (engineering characterizations / system validations)

    + Data analysis

    + Document review and management

    + 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.

    + Advanced data trending and evaluation.

    + Ability to evaluate compliance issues.

    + Available for administrative shift

     

    Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

     

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