Integra LifeSciences

  • Quality Inspector II

    Vacancy ID
    2018-28461
    Location
    US-NJ-Plainsboro
    Position Type
    Regular Full-Time
    Category
    Manufacturing
  • Overview

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    Responsibilities

    • Perform in-process inspections using a variety of measuring and test equipment to determine acceptance or rejection of material or products being produced.
    • Perform line clearances and quality reviews in manufacturing, labeling or other assigned areas during manufacturing activities.
    • A requirement of the role includes working in classified clean rooms.  Must be present in assigned production area for the duration of the shift.
    • Responsible for maintaining gowning qualification and for setting the standard for clean room behavior.
    • Interpret and work within the guidelines of specifications, charts, procedures and other data to determine acceptance or rejection of materials or products.
    • Maintain records of inspection and all testing performed on the appropriate test records
    • Discuss inspection results with those responsible for the product.  Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives
    • Monitor operations to ensure that production standards are met.  Escalate discrepancies to management for remediation.
    • Regularly review and maintain manufacturing log books and forms. 
    • Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
    • Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
    • Assist in training new associates according to QSR and company SOPs as applicable

    Qualifications

    • High School diploma (or GED). College education is preferred.
    • 2-5 years of relevant GMP/GLP experience specific to line-clearance and in-process inspections.
    • QA experience in the medical device or pharmaceutical industry is preferred.
    • Experience working in classified cleanrooms is preferred.
    • Attention to detail, strong organizational skills, and time management are essential.
    • Must have strong communication skills-both written and verbal. Must effectively communicate with other departments and have strong intrapersonal skills.
    • Must be self-directed, with strong problem solving skills.
    • Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP
    • Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), a plus.
    • Ability to define problems, collect data, establish facts and draw valid conclusions.
    • Ability to work effectively in a cross-functional environment.
    • Ability to integrate quality objectives across multiple functions
    • Must be able to work independently with minimal supervision.

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